FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing, OEI-01-20-00380
- Issuer
- Office of Inspector General
- Document type
- Brief
- Date
- 2020-05-31
Summary
A report by the U.S. Department of Health and Human Services Office of Inspector General, OEI-01-20-00380, dated September 2022, titled FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing. The review covers January 1 through May 31, 2020 and assesses how the Food and Drug Administration used its EUA authority to authorize COVID-19 diagnostic and serology tests. OIG reports that FDA issued over 100 EUAs for such tests in the first 5 months, and finds that efforts to increase test availability sometimes came at a cost to test quality. It draws on FDA documents, interviews and a survey of 237 test developers. OIG makes six recommendations, including new EUA templates and formal communication channels with the lab community, and states that FDA concurred with all of them.
Summary drafted by a model from the document's text below and checked by script against that text before publication. It is a navigation aid, not a reading of what the document proves. Where AI is used
Full text
U.S. Department of Health and Human Services
Office of Inspector General
FDA Repeatedly Adapted
Emergency Use Authorization
Policies To Address the Need
for COVID-19 Testing
Suzanne Murrin
Deputy Inspector General for Evaluation and Inspections
September 2022, OEI-01-20-00380
U.S. Department of Health and Human Services
Office of Inspector General
Report in Brief
September 2022, OEI-01-20-00380
Why OIG Did This Review FDA Repeatedly Adapted Emergency Use
At the start of the COVID-19
pandemic, no test existed to Authorization Policies To Address the Need
identify this novel virus. Testing for COVID-19 Testing
is vital to diagnose infected
individuals and understand When COVID-19 emerged, ensuring
spread during infectious disease Key Takeaway that tests were available to diagnose
emergencies. The Food and From January through May and track it became a vital public
Drug Administration (FDA) used 2020, FDA repeatedly adapted health goal. FDA used its EUA
its Emergency Use Authorization its approach to how it used authority to authorize tests and to
(EUA) authority to facilitate the Emergency Use Authorizations help ensure that the nation’s testing
development and availability of to address COVID-19 testing needs were met. The EUA authority
COVID-19 tests. Members of challenges and to expedite allows for a lower level of evidence
Congress have expressed strong access to tests. However, these for emergency medical products
interest in the availability and efforts to increase test compared to during nonemergency
effectiveness of both diagnostic availability sometimes came at situations. EUAs generally entail a
and serology tests. This review a cost to test quality. shorter review period while
assesses how FDA used its EUA maintaining an appropriate assurance
authority to authorize COVID-19 of quality.
tests during the crucial first
months of the pandemic. Over the first 5 months of the pandemic, FDA issued over 100 EUAs for
COVID-19 diagnostic tests, which identify an active infection, and
How OIG Did This Review serology tests, which identify prior infection. Because of the different
We focused our review on the purposes of these types of tests, FDA used different approaches to
early months of the pandemic: ensure that tests got to the market quickly and performed well.
January 1 through May 31, 2020.
We relied on FDA documents, What OIG Found
data, and interviews to The failure of the Centers for Disease Control and Prevention (CDC)’s first
determine how FDA conducted test rollout revealed vulnerabilities in the Federal approach to testing
EUA activities and decision- early in the COVID-19 pandemic. It is typical for CDC to be the first to
making. We surveyed and receive an EUA, and FDA expected that CDC’s test would meet the early
received responses from 237 test testing needs of the nation. However, CDC’s first test was unusable for
developers that engaged with many for weeks while no other test was authorized. Furthermore, due in
FDA about their COVID-19 tests part to its limited engagement with the public health labs that were using
and analyzed survey responses CDC’s test, FDA was slow to realize that testing by public health labs was
to assess experiences working far more limited than it initially expected. To address problems with the
with FDA. We also interviewed first authorized COVID-19 test, FDA worked with CDC, including allowing
test developers and CDC to modify the terms of its original EUA. However, preventing a
representatives from a similar problem from occurring in future emergencies would require
professional laboratory actions outside of FDA’s authority alone.
association for context about
In using its EUA authority, FDA also made calculated decisions to increase
developer experiences.
availability of COVID-19 testing, but these decisions often came at a
potential cost to test quality. FDA authorized tests using lower levels of
evidence to support developers struggling to access clinical samples.
FDA’s policies allowed diagnostic and serology tests to get on the market
quickly; however, that resulted in some problematic tests on the market,
requiring further action by FDA.
FDA’s decision to accept all EUA requests resulted in a record number of
submissions—often low-quality and from developers lacking experience
with FDA’s processes. In response, FDA took steps to support developers
and ease its workload, which included issuing EUA guidance, updating
templates (submission guides for developers requesting EUA), and
adjusting its EUA review process, among others. Some developers still
reported being frustrated and confused.
FDA’s experience using EUA for COVID-19 tests during the first few
months of the COVID-19 pandemic provided actionable insights about
the EUA process as well as a national testing strategy.
Summary of Actionable Insights
FDA addressed early testing challenges using EUA
flexibilities, but this experience underscores the need for a
national testing strategy.
FDA needs clear, direct communication with the lab
community during an emergency.
Developers require further FDA guidance on how to
validate tests during shortages of clinical samples.
Although policies that delay or forgo FDA review allow for
faster testing, without FDA review problematic tests reach
the market.
FDA needs contingency plans for resources to handle the
workload that the next emergency response may require.
Templates are useful tools for FDA to communicate
expectations for test development, validation, and
authorization.
Inexperienced test developers require more support from
FDA during the EUA process.
What OIG Recommends and How the Agency Responded
Our findings underscore the need to apply actionable insights from FDA’s
early experiences with the COVID-19 pandemic toward current and future
infectious disease emergencies to better balance test availability and
quality. We recommend that FDA:
• Assess and, as appropriate, revise guidance for test EUA submissions
• Develop a suite of EUA templates for future emergencies involving
novel pathogens
• Expand the FDA Center for Devices and Radiological Health’s existing
device-tracking platform to facilitate EUA submission and monitoring
• Expand and improve resources for test developers on the EUA process
• Establish formal communication channels between FDA and the lab
community, to be used in emergencies that require testing
• Work with Federal partners to implement lessons learned about a
national testing strategy that go beyond the EUA process
FDA concurred with all of our recommendations.
TABLE OF CONTENTS
BACKGROUND................................................................................................................................................ 1
Significant Events in Developing Tests for COVID-19: January Through May 2020........................................ 8
CDC’s COVID-19 Test: Highlights of Early Problems ................................................................................................... 9
FINDINGS....................................................................................................................................................... 10
FDA used its emergency use authorization flexibilities to help resolve the failure of the CDC test
rollout, but the engagement revealed vulnerabilities in the Federal approach to early emergency
testing.......................................................................................................................................................................................... 10
Facing the need for rapid expansion of COVID-19 testing, FDA eased EUA requirements to further
speed getting tests to market ............................................................................................................................................ 12
FDA’s decisions to reduce or forgo EUA requirements allowed problematic tests on the market .........16
A record number of EUA reviews led FDA to adjust its processes to better manage its workload, but
some test developers were confused and frustrated by these changes............................................................19
CONCLUSION AND RECOMMENDATIONS...........................................................................................27
Assess and, as appropriate, revise FDA guidance for test EUA submissions ...................................................28
Develop a suite of EUA templates for future emergencies involving novel pathogens ..............................28
Expand CDRH’s existing device-tracking platform to facilitate EUA submission and monitoring ...........29
Expand and improve resources for test developers on the EUA process ..........................................................29
Establish formal communication channels between FDA and the lab community, to be used in
emergencies that require testing ...................................................................................................................................... 30
Work with Federal partners to implement lessons learned about a national testing strategy outside
the EUA process....................................................................................................................................................................... 30
AGENCY COMMENTS AND OIG RESPONSE ....................................................................................... 32
APPENDIX ..................................................................................................................................................... 34
Appendix: Agency Comments............................................................................................................................................ 34
ACKNOWLEDGMENTS AND CONTACT ............................................................................................... 40
Contact........................................................................................................................................................................................ 40
ABOUT THE OFFICE OF INSPECTOR GENERAL..................................................................................... 41
ENDNOTES ................................................................................................................................................... 42
BACKGROUND
OBJECTIVE
To assess the effectiveness of FDA’s use of emergency use authorization (EUA) to
authorize tests for COVID-19.
In December 2019, a novel coronavirus caused unusual cases of pneumonia-like
illness in China. The illness soon came to be known as coronavirus disease 2019
(COVID-19).1, 2 The Centers for Disease Control and Prevention (CDC) confirmed the
first domestic case of COVID-19 in a patient in Washington State on January 20, 2020,
as the virus spread rapidly throughout the world. In response, the Secretary of Health
and Human Services declared a public health emergency on January 31. The World
Health Organization declared COVID-19 a pandemic on March 11, 2020, indicating
that COVID-19 had spread to countries across several continents, potentially affecting
a large number of people.3, 4, 5 As of May 25, 2022, CDC had reported over 83 million
cases in the U.S., and over one million deaths.6
Understanding how infectious diseases spread and whom they infect is paramount to
containing transmission.7 Testing is one of the most useful tools for disease
surveillance and for researchers to gain knowledge of the disease such as how it is
transmitted between individuals. Testing also allows diagnosed individuals to take
preventive measures to limit transmission to others. Without sufficient testing, efforts
to control a virus are significantly limited.
A diagnostic test for COVID-19 did not exist when the disease first began to spread;
such is the nature of a novel pathogen. Therefore, the first step for governments and
scientists around the world was to develop a diagnostic test.8 Indeed, early in the
outbreak, FDA stated that it was “actively working to facilitate the development and
availability of” tests to diagnose COVID-19, in part through its Emergency Use
Authorization (EUA) authority.9
FDA’s response to the COVID-19 pandemic is informed by its experiences responding
to outbreaks of the H1N1, Zika, and Ebola viruses. COVID-19 has presented many
new challenges to FDA, and with that, many actionable insights. This report aims to
evaluate FDA’s use of its EUA authority during the crucial first months of the
pandemic and to determine opportunities for improvement so that we are better
prepared for future emergencies.
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing
OEI-01-20-00380 Background | 1
FDA Emergency Use Authorization Authority
In part, FDA may use its EUA authority during a public health emergency to allow
entities to distribute and use unapproved medical products (or unapproved uses of
approved medical products) for the diagnosis, treatment, or prevention of serious or
life-threatening diseases.10, 11 This EUA authority allows FDA to facilitate these
medical products’ availability to respond to an emergency. Entities that request EUA
for their product may seek full approval for the product after authorization.12 To
initiate FDA’s EUA authority during COVID-19, the Secretary of Health and Human
Services determined that a public health emergency that has a significant potential to
affect national security or the health and security of U.S. citizens living abroad exists
and, on the basis of this determination, declared that circumstances exist to justify
EUA for certain products.13, 14, 15 The Secretary made this determination regarding
COVID-19 and declaration regarding tests for COVID-19 on February 4, 2020.16 EUA
for a product expires at the end of the relevant EUA declaration, which may extend
beyond the public health emergency declaration, or sooner if FDA revokes the
authorization.17,18
Exhibit 1. FDA must ensure that a product meets four statutory criteria for
EUA.
1. Condition/disease must be serious or life-threatening and caused by the agent
referred to in the Secretary’s declaration;
2. It is reasonable to believe based on the available scientific evidence that the
product may be effective to prevent, diagnose, or treat such serious or life-
threatening diseases or conditions caused by the agent referred to in the
Secretary’s declaration;
3. It is reasonable to believe based on the available scientific evidence that the
product’s known and potential benefits outweigh the known and potential risks,
taking into consideration the material threat posed by such disease or condition;
and
4. There are no adequate, approved, and available alternatives.
Source: Section 564 of the FD&C Act.
FDA’s EUA authority allows for a lower level of evidence compared to the statutory
criteria for approval or clearance through a traditional marketing pathway (see
Exhibit 1).19 Emergency product developers must demonstrate that there is a
“reasonable belief that the product may be effective,” rather than that there is a
“reasonable assurance of safety and effectiveness.”20, 21, 22 However, developers must
demonstrate a reasonable belief that “the product’s known and potential benefits
outweigh the known and potential risks.”23, 24, 25 This lower level of evidence allowed
during public health emergencies enables FDA to review and authorize these products
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing
OEI-01-20-00380 Background | 2
more quickly than products approved or cleared through traditional marketing
pathways.26
FDA’s EUA authority also allows for broad flexibility during an emergency in how FDA
will balance the need to facilitate the quick availability of medical products with
ensuring that these products meet quality standards. FDA may do this by engaging
with stakeholders early in an emergency to encourage them to develop and seek EUA
for medical products, establishing a required format for EUA submissions, and
determining how FDA reviewers process EUA requests. FDA may also be flexible with
the kinds of evidence standards that developers must meet to receive EUA.
The COVID-19 response is FDA’s most widespread use of EUA authority in response to
a single threat, though the authority has existed since 2004.27 FDA has used its EUA
authority in response to such threats as Avian Flu in 2013 and the Zika Virus in 2016.28
In response to the COVID-19 pandemic, FDA issued EUAs for a variety of medical
products—first for a diagnostic test, and then others to authorize the emergency use
of N-95 masks, ventilators, and other devices; drug treatments such as remdesivir; and
three vaccines that are each biologic products.
COVID-19 Test Regulation Within FDA
Within FDA, the Center for Devices and Radiological Health (CDRH) regulates medical
devices, which include products ranging from tongue depressors to pacemakers.29, 30, 31
CDRH approves and clears medical devices before they are marketed. It also works
with the Office of the Chief Scientist to authorize emergency use of medical devices
through the EUA pathway.32 Three independent teams within CDRH review COVID-19
tests: one each for molecular, antigen, and serology tests.33 Other teams carry out
pre-authorization reviews and post-authorization compliance monitoring and
surveillance.
Requesting and Issuing an EUA for an Emergency Test
Before requesting EUA, developers have the option to engage with FDA via a pre-EUA
process to determine whether their product meets FDA’s EUA evidence standards.
Developers can include government entities (such as CDC), commercial labs, and
hospital labs. Pre-EUA activities typically involve FDA reviewing data and documents
and providing feedback to developers to help ensure that their potential EUA request
is complete and ready for formal FDA review.34, 35
To formally request EUA, developers must submit required documents to FDA
(together, these documents are referred to as an EUA submission or request).36 To
receive EUA for a test, developers must meet FDA’s evidence standards to
demonstrate that their tests perform as intended (i.e., with a “reasonable belief” that
they are effective).37 Meeting these standards requires developers to submit
validation data to assess the potential for false test results, which can impact the care
of an individual patient and have public health implications.38 If a developer intends
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OEI-01-20-00380 Background | 3
to manufacture a test for distribution, it must also specify the name(s) of the
manufacturer(s) in their EUA request, which may include contract manufacturers.
Upon issuing EUA, FDA establishes conditions of authorization to protect public
health and safety.39 Developers must adhere to these conditions to continue using
their test. For example, to ensure that health care professionals understand how to
use tests and interpret test results, FDA establishes conditions that require developers
to provide “Fact Sheets” with this information. FDA places conditions that require
developers to collect information on the performance of their test and report
suspected false test results to FDA. FDA also establishes conditions requiring test
users, such as labs, to use the test as specified in the FDA-approved test labeling. To
modify their test or how their test may be used, developers must formally request
authorization for these changes from FDA.
EUA Post-Authorization Oversight and Enforcement
FDA reviews authorized products to ensure that they continue to meet the conditions
of authorization, including that their known and potential benefits outweigh their
known and potential risks, and that products do not jeopardize public health and
safety.40 For COVID-19 tests, FDA post-authorization oversight also involves ensuring
that all tests on the market have EUA (or do not require EUA to be on the market).
FDA oversees them by monitoring product performance, watching for signals about
the products from other sources, and receiving information from stakeholders.
FDA gathers information on tests in three ways: receiving allegations of regulatory
misconduct from stakeholders, direct reporting from developers, and conducting its
own surveillance. Allegations come from health care providers, patients, and other
stakeholders, and can include reports of false results or mislabeled products.
Reporting requirements include data on adverse events and test performance (e.g.,
false positives and false negatives), which developers submit to FDA as data become
available. Finally, CDRH reviewers conduct surveillance, such as monitoring websites
and promotional materials, for tests that are illegally on the market.
Reviewers begin a compliance investigation if they find evidence or receive
allegations that a COVID-19 test is being distributed or used in a manner inconsistent
with the letter of authorization. FDA may revoke an EUA if the test no longer meets
the conditions of authorization or presents public health or safety concerns.41, 42
Diagnostic and Serology COVID-19 Tests
FDA has authorized two general types of tests to diagnose current infection with, and
presence of antibodies for, COVID-19: diagnostic and serology.43 Diagnostic tests
identify active infection with COVID-19. Serology tests determine whether a patient
had COVID-19 by detecting antibodies in the blood, but should not be used to
diagnose active infection.44 See Exhibit 2 for details. These COVID-19 tests are in
vitro diagnostic tests. This means that they use patient samples, such as blood or
saliva, to indicate whether a patient has COVID-19 or COVID-19 antibodies.
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Exhibit 2. Types of COVID-19 tests
Test Type Detects Used to Result times
Diagnostic Molecular COVID-19 Diagnose active COVID-19 Less than
genetic material 1 day to
1 week
Antigen COVID-19 Diagnose active COVID-19 1 hour or
proteins less (may be
less reliable
than
molecular
tests)
Serology N/A Antibodies in Indicate prior COVID-19. Less than
the blood due Should not be used to 1 day to
to COVID-19 diagnose active COVID-19. 3 days
Source: FDA, COVID-19 Test Basics.
Accessed at https://www.fda.gov/consumers/consumer-updates/covid-19-test-basics on September 2,
2022.
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Methodology
Scope
This report focuses on the EUA process during the first few months of the COVID-19
health emergency. It includes all COVID-19 tests that FDA reviewed for authorization
from January 1 through May 31, 2020, and oversight FDA conducted on those tests
through December 31, 2020. Although FDA does not know the exact number, it
estimates that by late May 2020 it worked with more than 400 developers through the
pre-EUA and EUA processes and issued 117 EUAs for tests.45 FDA has continued to
issue EUAs after the review period of this evaluation. As of May 3, 2022, FDA issued
EUAs for over 400 tests, including 348 diagnostic and 85 serology tests.46
To conduct this study, we relied on multiple data sources: public and internal FDA
documents; interviews with test developers, FDA staff, and other stakeholders; and a
survey of test developers.
FDA Documents
We received data from FDA on its EUA policies and procedures, such as its standard
operating procedures for EUAs; all policies and procedures for requesting, reviewing,
and prioritizing EUA submissions; criteria for review decisions; and documents related
to oversight and enforcement, among other data. We also received a log of all test
developers that engaged in EUA and pre-EUA activities with FDA between January 1
and May 31, 2020. In addition, we acquired publicly available data, such as guidance
documents, lists of tests that received EUA, and information on tests that were subject
to oversight enforcement actions.
Interviews
We conducted interviews with four test developers and 11 FDA staff members,
including reviewers and officials within CDRH. We also conducted interviews with
other stakeholders, including a former FDA official and staff from a professional
laboratory association. We use the data from the test developer interviews as
examples and to provide context, but do not use them to generalize to all test
developers that sought EUA for COVID-19 tests.
Test Developer Survey
We sent a web-based survey to all test developers that contacted FDA about the EUA
or pre-EUA process between January 1 and May 31, 2020. FDA provided us with a list
of all EUA and pre-EUA submissions, including a contact email address for each
submission.
We sent our survey to all 967 unique email addresses on the EUA/pre-EUA log
provided by FDA. However, FDA informed us that the 967 email addresses may not
represent 967 unique test developers. Rather, some developers used unique email
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OEI-01-20-00380 Background | 6
addresses for each EUA or pre-EUA request they submitted, and others requested
EUA or pre-EUA for the same test multiple times using different names. FDA also
informed us that the log contains some test resellers and distributors that submitted
EUA requests for tests that FDA had already reviewed. Therefore, we do not know
(nor does FDA) the true population of unique test developers that contacted FDA
about COVID-19 tests.
Many of the contact emails on the list FDA provided were for contractors that test
developers hired to act as intermediaries for working with FDA. Several contractors
submitted multiple EUA applications for multiple test developers. Because we sought
information about test developers’ direct experiences with FDA and the EUA process,
we did not collect responses from contractors. Instead, we requested contact
information for the test developers with whom they worked, but only 22 out of over
100 contractors responded. We sent the web-based survey to all test developers
identified by the 22 contractors.
In total, 237 test developers responded to the survey.47 Therefore, data from the
survey represent the views and experiences of the 237 test developers that responded
to our survey rather than all test developers that contacted FDA about an EUA for
their test.
In the survey, we asked questions about the developers’ experiences working with
FDA, including whether FDA’s guidance, processes, and policies were helpful or
challenging. We also included several open-ended response options for developers
to provide more context about their experiences.
Analysis
We analyzed data provided by FDA to assess how FDA implemented EUA policies and
procedures and to construct a timeline of significant events related to EUAs for
COVID-19 tests in the first five months of 2020.
We analyzed interview data with test developers to inform the questions we asked in
our test developer survey. We also analyzed the interview data and the survey results
to provide context about the developer side of the EUA process.
Limitations
The results of our test developers survey are not projectable and only reflect the
experiences of the 237 test developers that responded to the survey.
Furthermore, we did not independently verify data provided by FDA, nor information
provided by FDA or test developers in interviews.
Standards
We conducted this study in accordance with the Quality Standards for Inspection and
Evaluation issued by the Council of the Inspectors General on Integrity and Efficiency.
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Significant Events in Developing Tests for COVID-19: January
Through May 2020
For reference throughout the report, below are some key events that took place
during the scope of our study, followed by an overview of early problems with CDC’s
test.
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CDC’s COVID-19 Test: Highlights of Early Problems
CDC develops a test for COVID-19: On January 9, 2020, FDA and CDC began
discussing the COVID-19 pandemic, including CDC’s progress toward developing a
test.
FDA authorizes CDC’s test: On February 4, FDA issued EUA for CDC’s test, a day after
receiving CDC’s complete submission for authorization.
PHLs report a problem with the test: On February 10, days after CDC made its test
available to 115 labs, including PHLs and Department of Defense (DoD) labs, CDC
notified FDA that 10 PHLs were reporting problems with one of the four components
of the test—the N3 component.48, 49 Each component has its own function in the test.
The N3 component was included to identify any virus in the coronavirus family that
causes severe acute respiratory syndrome (SARS) in case COVID-19 mutates.
Two days later, CDC reported to FDA that 26 PHLs had problems with the N3
component. On February 15, CDC reported that additional PHLs had problems with
the N1 component (on February 21, CDC clarified that six labs had issues with the N1
component). PHLs were unable to use tests that had problems; however, some labs,
including CDC itself, were able to continue testing.
Some PHLs reported problems with two components of CDC’s test.
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FINDINGS
FDA used its emergency use authorization flexibilities to help
resolve the failure of the CDC test rollout, but the engagement
revealed vulnerabilities in the Federal approach to early
emergency testing
As previously noted, FDA issued the first EUA for a COVID-19 diagnostic test to CDC
on February 4, 2020. CDC was the first test developer to request and receive EUA,
which is typical because CDC is often the first U.S. entity to obtain samples for novel
pathogens. Obtaining these samples allows developers to validate their tests, a key
element of an EUA request because it demonstrates that the test performs as
intended.50 Thus, CDC’s early access to clinical samples gives it a considerable head
start over commercial developers. Even so, CDC was not able to obtain a sample to
validate its test until it identified a case in the U.S.
CDC’s position as the only developer with an authorized COVID-19 test proved
problematic when PHLs reported concerns with certain components of the test.
Although FDA noted a robust pipeline of
private developers interested in
requesting EUA for COVID-19 tests in “We were working with CDC daily to
January and February 2020, CDC’s was explore various options to address the
the only test in the nation with EUA until problems observed with their
February 29. With no Federal plan to fill distributed test… We had reviewers on
the gap in testing when the CDC test standby through the weekends, ready
failed, FDA worked with CDC to solve the to review such requests.” – FDA official
problems while continuing to engage
with private developers.
FDA allowed modifications to CDC’s existing EUA to address problems and increase
testing. FDA and CDC agreed on a dual approach to resolving this issue; both
approaches would require authorization from FDA. First, during a February 10 call,
CDC told FDA that it suspected the problem occurred during the manufacturing
process. To address this, FDA and CDC agreed that commercial vendors could
manufacture CDC’s test or problematic components of CDC’s test. CDC initially used
its own facilities to manufacture its COVID-19 test. FDA suggested that CDC request
to include two contracted manufacturers in its EUA. Once FDA approved that, the
contractors produced and distributed millions of CDC’s tests within weeks. Second,
on February 15, CDC began considering contingency plans that would require further
modifications to its existing EUA so that PHLs could use the tests they had until the
replacements arrived. On February 26, after receiving data from CDC confirming that
dropping the N3 component would not adversely affect test results, FDA allowed
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PHLs to drop the N3 component if they had problems with only this component of
the test. FDA drafted proposed instructions for PHLs and, together with CDC,
communicated that PHLs could proceed with testing in this way.51
FDA had to take additional steps to ensure that CDC’s EUA modifications were
appropriate. After learning on February 21 that CDC had not yet confirmed the cause
of the problem, FDA immediately sent an official onsite to CDC laboratories to
conduct FDA’s own assessment. Identifying a manufacturing problem would allow
FDA and CDC to continue with their approach to resolving this problem; identifying a
design problem would require CDC to seek authorization for a new test. The FDA
official ultimately concluded that CDC’s test design was sound and the problem was
caused by contamination during manufacturing.
Overall, to address the problems with the CDC test rollout, FDA used its EUA authority
to an extent that it had not in previous emergency responses. Notably, FDA and CDC
worked closely throughout February and March to pursue opportunities to expand
access to testing under CDC’s EUA. As one FDA official put it, “In all, there were
several actions underway simultaneously, all of which were targeted to increasing
testing capacity.” See Exhibit 3 for other examples of how FDA engaged with CDC.
Exhibit 3. Examples of how FDA worked with CDC to increase the availability
of diagnostic tests under CDC’s EUA
Facilitated negotiations between CDC contract manufacturers to ensure that “research use only” tests
could be offered for immediate clinical use under CDC’s EUA.
February 27: CDC’s manufacturer began distributing hundreds of research use only tests.
Proposed and encouraged CDC to allow other EUA developers to use CDC’s test design and data to
demonstrate that their test’s performance is comparable to CDC’s test.
February 29: The New York State Department of Health received an EUA using this approach. This
was expanded to all developers in March.
Encouraged CDC to allow any lab to use kits manufactured under CDC’s EUA.
First week of March: Over 1 million tests released.
Second week of March: Over 5 million tests released.
Third week of March: Over 10 million tests released.
Source: Document submitted to the Homeland Security & Governmental Affairs Committee (2021).
Because FDA was only directly engaged with developers through its EUA process, FDA
was slow to realize that testing within PHLs was far more limited than it had initially
expected. Regarding authorized tests, FDA communicates directly with developers,
not with the labs implementing them. For this reason, FDA was not initially engaged
with PHLs. As a result, FDA was unaware that testing within PHLs was very limited and
may not have provided sufficient testing. FDA assumed that dozens of PHLs, in
addition to CDC, were using CDC’s original test and could meet the testing needs of
the nation until other test developers received authorization for their own tests.
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However, FDA learned from media sources that far fewer PHLs were testing than
expected. On February 21, when FDA requested clarification from CDC about the use
of the authorized COVID-19 test, CDC “surprised FDA” by reporting that only seven
PHLs were using the test. CDC assured FDA that the testing at these seven sites and
increased testing capacity in CDC’s Atlanta facilities were meeting the needs of the
nation.52
On February 24, FDA was again alerted to the possibility that U.S. testing needs were
not being met by the CDC test. The Association of Public Health Laboratories (APHL)
wrote to then FDA Commissioner Dr. Stephen Hahn to urge FDA to allow certain PHLs
to immediately start using non-CDC tests developed in their own labs.53, 54 Letters
from APHL and other stakeholders also led FDA to recognize that many in the lab
community did not know that they could have sought EUA for their own tests.55 After
receiving APHL’s letter, FDA began to join regular calls between CDC and APHL. FDA
also started to consider policies to speed up test availability.
Actionable Insights
FDA addressed early testing challenges using EUA
flexibilities, but this experience underscores the need for a
national testing strategy.
FDA needs clear, direct communication with the lab
community during an emergency.
Facing the need for rapid expansion of COVID-19 testing, FDA
eased EUA requirements to further speed getting tests to
market
As COVID-19 spread across the country, robust testing became increasingly urgent.
The demand for diagnostic tests was growing exponentially and the pressure was
high for FDA to take steps to immediately increase diagnostic test availability. This
urgency increased after FDA learned that not as many PHLs were using CDC’s test as
expected. In addition, serology tests were in demand to help researchers understand
COVID-19 immunity and how the disease spreads.
To respond to this need, FDA took advantage of the flexibilities in the EUA process to
address testing challenges the country was facing. Although the EUA process already
allows developers to get their tests to the market faster than through traditional
marketing pathways, FDA further eased various EUA requirements.
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To help developers overcome clinical sample shortages, FDA
authorized tests using lower evidence standards
In mid-February 2020, FDA learned that developers were struggling to access clinical
samples needed to validate tests, preventing them from requesting EUA. Although
limited access to clinical samples is a typical problem when infectious diseases
emerge outside of the U.S., this challenge became even more urgent in the wake of
the CDC test rollout failure. Some samples were available in mid- to late February;
however, only certain developers, such as those qualified to handle live viral material,
could access the material. The larger developer community had limited access to
clinical samples, or other kinds of acceptable validation material, until mid- to late
March. Indeed, of the developers that responded to our survey and attempted to
obtain validation material, 77 percent (173 out of 226) found obtaining validation
materials to be challenging or somewhat challenging. FDA staff also told us that
accessing validation material was the most common challenge reported to FDA early
in the pandemic.
FDA responded by using its EUA
flexibilities. FDA accepted “[The smaller set of samples] is just really,
validation studies that used
really a low bar. But [the] EUA process allows
contrived samples to help test
us to do that and match our requests to the
developers overcome
situation on the ground.” – FDA official
challenges accessing clinical
samples. This was more
achievable for developers, while
still demonstrating acceptable performance. On February 29, FDA announced that it
would recommend that developers use a smaller set of patient samples, which FDA
determined was just enough to be able to demonstrate acceptable performance. FDA
also recommended that developers use more contrived samples than previously
required.56, 57 A contrived sample is made by “spiking” human specimens with COVID-
19 material (such as inactivated virus).58, 59 Although contrived samples are easier to
access, they are less reliable than patient samples.60 In total, FDA authorized 59 EUA
requests based on validation using contrived samples, although in May 2020 FDA
began to recommend clinical samples for validation since these were more easily
available at this point.
Although FDA’s approach addressed the challenges of validating tests and getting
them on the market faster, FDA also recognized that this approach introduced
potential uncertainty into test results. As one FDA reviewer stated, “at the beginning
of an outbreak we do have to compromise, and that’s really the nature of the
outbreak.” To help address this uncertainty, FDA sent standardized validation
material to all molecular test developers, including those that previously used
contrived samples as well as those seeking EUA. Using this material allowed potential
users of tests to compare performance results among tests.
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Actionable Insight
Developers require further FDA guidance on how to validate
tests during shortages of clinical samples.
FDA allowed test developers to delay or forgo EUA review so that
they could immediately begin testing
FDA made several policy announcements to quickly increase the availability of tests
(see Exhibit 4). These policies were “notification policies,” which meant that
developers could delay or forgo FDA review and begin testing or distributing their
tests right away, as long as they notified FDA and validated the tests first.
Within a week of FDA issuing the February 29 notification policy, which allowed
qualified labs to begin testing before submitting an EUA request, seven labs notified
FDA that they would begin testing. By late March, 65 labs notified FDA that they
would test under this policy, and by May 11, 2.5 months after the original policy
announcement, this increased to 245 labs.61, 62
Unlike the February 29 notification policy, FDA’s March 16 notification policy for
commercial diagnostic test manufacturers generated little interest. An FDA official
told us that relatively few commercial manufacturers took advantage of the policy and
most chose to proceed with an EUA request before distributing their tests. While it is
unclear why so few chose to take advantage of this policy, one developer that
completed our survey and chose this route noted that, because its test had not yet
received formal EUA, insurance payers did not pay for it.63 Developers are also
qualified for certain liability protections under the Public Readiness and Emergency
Preparedness Act when their tests have EUA.64
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Exhibit 4. FDA issued five notification policies to increase test availability.*
Type of test Date Developers Details
February 29 Certain labs Before use, qualified labs must validate the
Diagnostic qualified for high- test; notify FDA via email; submit a full request
complexity work for EUA within 15 business days of notifying
FDA.
March 16 Commercial Before use and distribution, developers must
manufacturers validate the test; notify FDA via email; submit
a EUA request within 15 business days of
notifying FDA.
Serology March 16 All developers No EUA required if developer validates the
test; notifies FDA; provides appropriate
information with the test
May 4 Commercial Revision to March 16 serology policy. Before
manufacturers use and distribution, developers must validate
the test; notify FDA via email; submit a full
request for EUA within 10 business days of
notifying FDA.
All tests65 March 16 Certain labs FDA granted flexibility for States to oversee
(March 12 for qualified for high- COVID-19 tests developed and used by
New York) complexity work qualified labs within that State if the State
notifies FDA first.
*FDA no longer allows additional developers or States to use any notification policy as of November 15, 2021.
Source: FDA Statements made on February 29, March 16, and May 4, 2020.66, 67, 68
FDA’s initial notification policy for serology tests, issued on March 16, allowed
serology tests on the market with even more relaxed requirements than those for
diagnostic tests. In mid-March, FDA stated that the value of serology tests lies mainly
in advancing the scientific community’s understanding of COVID-19.69, 70 Serology
tests cannot be used to diagnose an active infection with COVID-19 and had limited
use in prior emergencies.71 Therefore, FDA made a strategic decision to focus its
limited resources on authorizing diagnostic tests rather than serology tests. The
March 16 notification policy stated that serology test developers could request EUA
for their tests or put their test on the market without EUA if the developer met certain
conditions. To help ensure that serology tests were used appropriately, FDA limited
this policy to certain qualified labs.72, 73, 74 By the end of April, 164 commercially
manufactured serology tests were on the market via the notification policy.75
To help test developers respond to supply shortages, FDA
allowed developers to forgo seeking EUA amendments for
substituting supplies
When shortages emerged in March 2020, FDA recommended that developers use
substitute supplies without an EUA amendment, which typically would have been
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required. Manufacturers struggled to keep up with demand for certain supplies, such
as reagents and nasal swabs, which the U.S. National Stockpile does not stock. When
a developer demonstrated that an alternative product could be an acceptable
substitute, FDA recommended that other developers make these substitutions
without requesting an EUA amendment. To further support national efforts to
address the supply shortage, FDA staff prioritized reviewing EUA submissions for tests
that did not rely on supplies that were difficult to access.
FDA also took steps outside of its traditional role to ease supply shortages. Although
FDA does not traditionally procure supplies, FDA worked with other government
entities, including the Department of Defense (DoD) and the Federal Emergency
Management Agency, to advise and coordinate procuring supplies. FDA worked with
the Biomedical Advanced Research and Development Authority (BARDA) and DoD to
coordinate military airlifts of swabs out of northern Italy to the U.S. In addition, FDA
contacted over 1,000 manufacturers to gain insights on shortages and potential
shortages, although it heard back from only around a third.76 As one FDA official
described FDA’s approach to addressing testing supply shortages, FDA was “actively
seeking and promoting different solutions to meet… the needs on the ground.”
FDA’s decisions to reduce or forgo EUA requirements allowed
problematic tests on the market
FDA successfully used the flexibilities in the EUA process to help make more tests
available faster. However, when FDA allowed labs to use tests before requesting EUA,
or to not require EUA at all, problems arose.
FDA found that many diagnostic tests on the market via the
notification policies had performance problems
FDA identified numerous tests with potential performance problems after issuing its
notification policies for diagnostics tests. Indeed, although FDA designed its
notification policies to expedite access to diagnostic tests, it was aware of potential
tradeoffs with poorer test performance. Of the seven labs that notified FDA in the
first week after the February 29 notification policy that they were going to start
testing and submit an EUA request later, one lab ultimately withdrew its test due to
contamination and three other labs had design or validation problems with their tests.
A later FDA analysis of 125 EUA requests for lab-developed diagnostic tests found
that 82 tests had design or validation problems. FDA identified similar problems with
commercial tests.77
Problematic tests were on the market and being used for the time span between
notification and FDA review and action.78 Weeks or months may have passed before
FDA reviewed the EUA request and required a developer to correct performance
problems. This may have led to patients receiving false positive or false negative test
results; the public health implications of the policy remain unclear. In addition,
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because tests on the market via notification policies had not yet received EUA,
developers of these tests did not have to meet conditions of authorization to report
test performance concerns. To counter the delay in identifying problems, in May
2020 FDA began prioritizing review of tests on the market via the notification policy.
FDA determined that allowing developers to market serology
tests with no EUA led to a concerning number of poorly
performing and inappropriately marketed serology tests, which
required FDA action
Removing the requirement for EUA review allowed problematic serology tests on the
market. By April 2020, around a month after the policy was announced, FDA became
aware of a “flood” of poorly performing and inappropriately marketed serology
tests.79, 80 Some tests did not perform as expected, and others came with false claims
to diagnose COVID-19 or to have FDA approval (no serology test for COVID-19 had
FDA approval). Stakeholders were also using or considering using serology tests for
purposes outside of advancing scientific knowledge.81, 82 FDA officials have since
publicly stated: “in hindsight, however, we realized that the policy outlined in our
March 16 guidance was flawed” and point to this experience to show the importance
of EUA review.83
Spurred by concerns about serology
tests already on the market, FDA began “It’s to our knowledge that this is the
to take actions. By the end of April, first time the U.S. government has
more than 150 serology tests were on
formally done testing of [in vitro
the market without EUA.84 That month,
diagnostic] products and used that
FDA issued a letter to health care
testing to make regulatory decisions.”
providers cautioning them against using
serology tests for diagnostic purposes – FDA official
and warning them about mislabeled
tests.85, 86 It also announced a
partnership with the National Institutes of Health, CDC, and BARDA to validate
serology tests within the National Cancer Institute’s (NCI’s) labs. FDA worked with
NCI to evaluate commercial manufacturers’ serology tests, both those already on the
market via the notification policy and tests not yet on the market for which FDA
needed additional data to support an EUA. FDA used the raw data sent by NCI to
inform its regulatory decisions.87 FDA posted performance reports for each evaluation
on its website.88 By early 2021, FDA found that two-thirds of EUA requests for
serology tests that NCI evaluated did not have adequate performance data.
FDA took further action in May by requiring EUA review for certain tests already on
the market. At this point, only 12 of the dozens of tests on the market had
undergone EUA review (developers could still choose to request EUA under the March
16 notification policy).89 On May 4, FDA announced a notification policy requiring
commercial serology test manufacturers to request EUA within 10 business days of
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putting validated tests on the market, including tests already on the market.
Developers could still use and distribute their tests after requesting EUA. FDA
required manufacturers that chose not to seek EUA to suspend distribution of their
tests.90, 91 In March, it created an online list of serology tests that it permits to remain
on the market. 92, 93 By November 2020, FDA had removed 167 serology tests from
this list.
In addition, most FDA post-authorization actions related to COVID testing in 2020
were for serology tests (see Exhibit 5). For example, FDA issued import alerts for
nearly 80 inappropriately marketed serology tests that manufacturers from other
countries were attempting to sell in the U.S. FDA issues import alerts to the public;
devices on the import alert list are detained at the border and prevented from
entering circulation until FDA receives evidence to overcome the appearance of the
violation.94
Exhibit 5. Throughout 2020, most post-authorization actions to address
mislabeling and performance concerns for COVID-19 tests were for serology
tests.
*Voluntary recalls are initiated by the manufacturer and conducted in accordance with 21 CFR Part 806.
**This does not include two warning letters for entities offering violative serology and diagnostic tests.
Source: FDA data provided to OIG.
Actionable Insight
Although policies that delay or forgo FDA review allow for faster
testing, without FDA review problematic tests reach the market.
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A record number of EUA reviews led FDA to adjust its processes
to better manage its workload, but some test developers were
confused and frustrated by these changes
From January through May 2020, as demand for tests skyrocketed, FDA reviewed all
EUA requests, regardless of the submission’s quality. An FDA official explained: “In
the absence of a national testing strategy, …we had to take an all-comers approach
and it’s one of the reasons why there were so many tests authorized in the U.S.
marketplace.” FDA reviewers interacted with developers primarily over email, working
nights and weekends to authorize as many COVID-19 tests as possible. FDA
developed new strategies to manage this unprecedented workload, but FDA staff
were already overloaded with review work while they were spending additional time
developing these strategies. In addition, some of FDA’s efforts frustrated and
confused test developers.
FDA reviewed a record number of EUA requests for COVID-19
tests, including a high number of low-quality submissions
Test developers inundated FDA with requests for EUAs in the first few months of the
pandemic. According to an FDA official, FDA microbiology division staff process
around 100 in vitro diagnostic test applications in a typical, nonpandemic year.
During this study’s time frame of January through May 2020, FDA staff received over
100 EUA requests per month for 3 consecutive months (see Exhibit 6), which was in
addition to their usual device approval work. In January 2021, nearly a year after the
public health emergency began, the FDA official told us the volumes of requests were
still over 100 per month.
Exhibit 6. EUA requests for COVID-19 tests increased substantially from
February through May 2020.
Note: FDA did not receive any EUA requests in January 2020.
Source: FDA data provided to OIG.
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During the first year of COVID-19, FDA issued more EUAs for tests than during all
prior emergencies combined. For example, during the H1N1 influenza pandemic of
2009, the last pandemic to affect a large number of people in the U.S. prior to
COVID-19, FDA issued 17 EUAs for H1N1 tests in a 12-month period.95 In
comparison, during the first 12-month period of the COVID-19 pandemic, FDA issued
320 EUAs for COVID-19 tests.96 During our review period, January-May 2020, FDA
authorized 117 tests (see Exhibit 7), and over the following 12 months, it authorized
an additional 101 of the 731 tests that developers submitted for authorization during
our review period.
Exhibit 7. FDA issued over 100 EUAs for COVID-19 tests by the end of May
2020.
Note: FDA did not issue any EUAs for COVID-19 tests in January 2020.
Source: FDA data provided to OIG.
Furthermore, FDA staff reported that most EUA submissions were low-quality, and this
contributed to reviewer workload. Low-quality
EUA submissions include those that were missing
necessary data or contained data that failed to “A lot of the submissions we
meet FDA’s standards. FDA reviewers got were very poor quality
communicated with test developers, requesting and all of that ate up our
additional data and studies, until they could time.” – FDA official
determine if the test met authorization standards.
One lead reviewer estimated that 80 percent of
submissions needed revisions.
Finally, developers inexperienced with FDA’s processes also took FDA reviewers’ time,
which contributed to their heavy workloads. One reviewer told us, “it’s smaller device
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manufacturers and laboratories who have not interacted with the regulatory
environment much before, who struggle meeting our criteria.” In fact, most test
developers that responded to OIG’s survey indicated that their experiences with FDA
were limited: only 13 percent of respondents (31 of 237) had requested an EUA for a
non-COVID-19 product in the past and just 28 percent of respondents (67 of 237) had
gone through any FDA approval or clearance process at all. Experience appeared to
help developers: 91 percent of survey respondents who had experience working with
FDA on both an EUA and a regular device approval (20 of 22) received EUA for their
first submitted COVID-19 test, compared to 40 percent of those with no experience
(64 of 159). One FDA staff member who was responsible for responding to emails
full-time for the first few months of the pandemic told us that those with less
experience “had no idea… how things should be done” and required “another level” of
support.
Actionable Insight
FDA needs contingency plans for resources to handle the
workload that the next emergency response may require.
FDA spent time and resources offering special assistance to make
the EUA process clear and accessible to test developers, but
developers voiced concerns about evolving expectations
Facing the urgent need for authorized tests, FDA took steps to make the EUA process
clear and accessible to potential developers, many of which had never worked with
FDA.
Templates. FDA developed templates for test developers to use in submitting EUA
requests to FDA for COVID-19 tests. These templates provided a roadmap for
developers to meet FDA’s standards for test development, validation, and
authorization.97 FDA created the templates based on feedback it had received from
test developers in prior emergencies in which developers reported that FDA’s
processes were not transparent.
Many test developers that responded to OIG’s survey benefitted from the templates
(see Exhibit 8). For example, one test developer volunteered, “The difficulty was prior
to Feb 29, 2020 when the obstacles were so high that we could not apply for an EUA
and thus had no testing. When FDA changed the requirements and provided a
template, it was much more straightforward.” Another explained how helpful it was
to have a template to follow, saying it was “very clear in laying out exactly how we
needed to validate our test and how we needed to present our validation data.”
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Exhibit 8. Developers who responded to OIG’s survey found FDA’s COVID-19
test templates accessible and helpful.
*191 out of 233 developers that accessed a test template
**222 out of 232 developers that used a template’s requirement instructions
Source: OIG analysis of OIG survey data.
By May 31, FDA had revised one of its templates six times. FDA streamlined its
original template for molecular tests by reducing it from 30 to 9 pages. FDA also
modified the template to reflect new information and situations, such as knowledge
about the virus or test component shortages. For example, FDA modified the
template to recommend contrived samples for validating a test, and then modified it
again when clinical samples were more widely available. This meant that a test
developer that submitted its EUA request under the contrived samples template could
be surprised to find that FDA would no longer accept its data by the time FDA began
its review. The developer would then have to redo the same experiments with clinical
samples to meet the requirements of the new template.
Adapting to FDA’s changing
templates proved frustrating for
“Between when I submitted my application
some developers. In fact, 65
percent of developers that for EUA and when it was reviewed, the
responded to our survey (153 out template was changed. I found it difficult
of 237) indicated that adapting to to follow the process, to know what was
FDA’s changing requirements was expected of my lab, and to keep up with
challenging or somewhat the changes.” – Test developer, OIG survey
challenging. In addition, FDA did
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not provide a template for antigen tests (e.g., rapid tests for home use) until May 11,
2020. Staff at one antigen test developer told us they were frustrated by FDA’s
expectations for antigen test authorization, which they found particularly unclear prior
to FDA releasing the antigen template. They, along with other survey respondents,
reported having to resubmit data several times only for FDA to “move the goalpost”
and deny EUA.
Nevertheless, FDA officials told us that the templates for the COVID-19 test EUA
requests, and their revisions, allowed them to streamline their review and enabled
authorization to occur more efficiently. Over time, templates came to include enough
detailed information for test developers to submit a complete EUA request with
minimal interaction with reviewers, including via pre-EUA. FDA emphasized the
importance of creating templates that target different pathogens in advance of
emergencies as a key lesson learned from this pandemic.
Guidance documents. FDA published guidance and updated policies on its website
to further support test developers. For example, FDA published “Policy for
Coronavirus Disease-2019 Tests During the Public Health Emergency” on February 29,
2020, and revised it several times. Although 89 percent of test developers that
responded to OIG’s survey (210 of 237) found the documents helpful or somewhat
helpful, 65 percent (154 of 237) found keeping track of updates to FDA’s EUA policies
challenging or somewhat challenging. One developer volunteered that it is
“frustrating and costly… when new guidance or requirements are issued constantly.”
Another was more specific in its criticism: “Conflicting guidances and being held to
changing requirements in the EUA template dictated that experiments were
performed multiple times at significant expense. This was not tenable and disrupted
patient testing during the early stages of the pandemic.”
Electronic submissions. FDA changed its longstanding protocol of requiring
developers to deliver all EUA requests in hard copy form. Experienced developers
were accustomed to this requirement, but those that had not worked with FDA found
it overly burdensome. Because this was a barrier for some developers during a time
when the country urgently needed tests, FDA began accepting all submissions
through email in February 2020.
Dedicated email boxes for test
developers. To help manage the
influx of emails from potential test “I cannot emphasize enough the
developers, FDA initially created convenience and how truly nice it was to
a general email box for stakeholders have supplements and amendments be
to direct questions about tests, submitted to specific email boxes.” –
supply shortages, and the EUA Test developer, OIG survey
process. Because test developers
quickly inundated the inbox with
“thousands of emails,” FDA assigned
two people to staff the email box 18-plus hours per day. FDA went further and
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created dedicated email boxes for specific aspects of the EUA process, such as an
email box for test developers that had received an EUA to send amendment
submissions when changes to a test became necessary. Of test developers that
responded to our survey and used the email boxes, 89 percent (185 of 207) found
them helpful or somewhat helpful. One developer told us it sent a few questions to
the general email box and “whoever was working on that email box was very
responsive.”
Town Halls. In March 2020, FDA began holding
weekly virtual Town Halls to provide developers the
“[T]he weekly FDA town hall
opportunity to ask technical questions about
calls that are ongoing have
developing and validating COVID-19 tests. FDA
been a tremendous resource!”
also used Town Halls as an opportunity for experts
– Test developer, OIG survey to make announcements, answer general
questions, listen to concerns to address on the call
or take back to the Agency to consider, and give
developers insight into its review processes. An FDA official said all the major
associations and other stakeholders participated; the official called the Town Halls “a
great way to reach in the community very quickly.” Of test developers that responded
to our survey and participated in the Town Halls, 89 percent (167 of 187) found them
helpful or somewhat helpful.
Frequently Asked Questions section of FDA’s website. FDA added a FAQ
section to its website in March 2020 to address questions related to COVID-19 tests
and the EUA process. FDA updated the FAQ page frequently to address questions it
received through emails. Of test developers that responded to our survey, 89 percent
(211 of 237) found the FAQs helpful or somewhat helpful. For some, the FAQ page
became a go-to source for updated information during the rapidly evolving
pandemic. For example, one developer we interviewed would review the FAQ page
“every single morning” during the first year of the pandemic.
Actionable Insights
Templates are useful tools for FDA to communicate
expectations for test development, validation, and
authorization.
Inexperienced test developers require more support from
FDA during the EUA process.
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FDA eased staff workload by adjusting its internal review process;
test developers voiced frustration with a lack of transparency
regarding these changes and the review process
In the face of the highest-ever volume of EUA requests, FDA told us it was short on
staff. To assist reviewers, some staff with infectious disease experience from other
FDA Centers transferred to CDRH. CDRH was also able to hire staff from outside FDA.
Still, the volume of EUA submissions overwhelmed reviewers—one told us, “Our
workload was unprecedented… I’m not sure if I’ve ever had 28 submissions on my
workload. Not even half that.” This unsustainable workload impeded FDA’s ability to
effectively respond to the pandemic.
In May 2020, after months of reviewing all tests submitted for EUA, FDA began
adjusting internal review procedures to better manage its increasing EUA-related
workload. A key component of the revised review procedures was the EUA
prioritization policy that informally started in May 2020.98 FDA prioritized review for
tests that could increase accessibility (e.g., at-home tests), could enhance testing
capacity (e.g., tests that allow processing of thousands of samples per day, per
instrument), or were already allowed on the market without FDA review. FDA also
began to decline to review some tests, such as those that processed low volumes, and
declined to issue EUA for tests with incomplete EUA submissions rather than allowing
developers to revise their submissions multiple times. FDA staff told us that the
prioritization process was helpful in easing the strain on FDA resources and meeting
public health needs.
However, some test developers
reported that FDA’s prioritization
“It was difficult to know why the FDA was not
policy was unclear. FDA first
communicated the prioritization reviewing our application. It was unclear
policy to the developer community what the priorities were for review. It was
during a Town Hall in May 2020. unknown what a company could do to
Developers that attended Town escalate review.” – Test developer, OIG survey
Halls reported being confused
about the specifics of the
prioritization policy. For example,
one developer stated, “FDA did not give a direct answer to our questions about how
they prioritize the applications for review.” In addition, not all developers attended
Town Halls: 21 percent of our survey respondents (50 out of 237) did not and thus did
not receive the message.
Furthermore, some test developers that responded to our survey reported a lack of
transparency from FDA on the status of their tests’ reviews. One stated that it did not
receive “clear or formal communication when our EUA review paused and then was
rejected as it was similar to an [existing] EUA test.” Others complained about not
hearing from FDA for weeks or months while they waited for their tests to be
reviewed. Some survey respondents expressed a desire for FDA to be more
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transparent about the review process, and two specifically suggested that FDA should
institute a tracking system so developers would know where their tests are in the
process.
FDA did not finalize the prioritization policy until October 2020. By this time, some
developers that received a “decline to review” decision, meaning their submission was
deprioritized, had been awaiting FDA’s response for 5 months or more.
In November 2020, FDA took
further steps to speed review and “[W]e were overwhelmed with submissions
ease workload on reviewers by that had issues, and that would just take too
giving developers 24 to 48 hours long of a time to be resolved interactively. So
to respond to their comments. we changed processes and limited the
According to survey respondents, interactive review and set priorities for what
responding to comments often
the agency thought would address the public
includes rerunning studies and
health need the most.” – FDA staff
resubmitting data. If a test
developer misses the time limit,
then the reviewer may deny
authorization. Thirty-two percent (76 out of 237) of developers that responded to our
survey stated that meeting FDA’s time frames for data requests was challenging or
somewhat challenging. Nevertheless, FDA suggested that limiting interactive review
relieved workload and allowed reviewers to efficiently manage their EUA submissions.
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OEI-01-20-00380 Findings | 26
CONCLUSION AND RECOMMENDATIONS
FDA’s experience using the EUA process during the first few months of the COVID-19
pandemic provided actionable insights about the EUA process as well as a national
testing strategy.
Summary of Actionable Insights
FDA addressed early testing challenges using EUA flexibilities, but this
experience underscores the need for a national testing strategy.
FDA needs clear, direct communication with the lab community during an
emergency.
Developers require further FDA guidance on how to validate tests during
shortages of clinical samples.
Although policies that delay or forgo FDA review allow for faster testing,
without FDA review problematic tests reach the market.
FDA needs contingency plans for resources to handle the workload that the
next emergency response may require.
Templates are useful tools for FDA to communicate expectations for test
development, validation, and authorization.
Inexperienced test developers require more support from FDA during the
EUA process.
Robust testing is crucial to responding to emergencies that involve infectious
diseases. It not only identifies infected individuals but also promotes understanding
of how a disease spreads. FDA’s EUA authority offers FDA significant flexibility in how
it can respond to testing needs during an emergency. FDA took advantage of this
flexibility to help address CDC test problems and to increase testing availability.
However, the U.S.’s early reliance on CDC as the sole manufacturer of its test, the
inability to directly address sample and supply shortages, and resource limitations as
FDA reviewers attempted to manage the influx of EUA reviews constrained FDA’s
response.
Balancing the need for test availability with test performance amidst an
unprecedented pandemic was difficult for FDA to navigate. No roadmap existed to
achieve that balance, so FDA made calculated decisions that prioritized testing
availability. This meant that poorly performing tests reached the market, although
how many were ultimately used or the impact on public health remains unknown.
Given the early experience of the pandemic, FDA has an opportunity to better plan for
and respond to current and future public health emergencies. Indeed, FDA has
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OEI-01-20-00380 Conclusion and Recommendations | 27
expressed its interest to apply lessons learned and be better positioned to facilitate
testing that balances speed to market with quality. For example, FDA officials
underscore the need for multiple entities to manufacture tests early in an outbreak.
In addition, FDA is considering steps to ensure a shared understanding of
nontraditional validation materials, such as synthetic material, to support EUA
requests. This could include developing formal standards and guidelines on when it
would be appropriate to use this material. Finally, an FDA official told us that FDA
should be more engaged with communications among CDC and the lab testing
community, including APHL.
To prepare for and respond to current and future emergencies, we recommend that
FDA:
Assess and, as appropriate, revise FDA guidance for test EUA
submissions
FDA issued various policies to increase testing availability and to adjust review
processes to manage increased EUA submission levels. FDA summarized and
communicated these policies in a guidance document, which it issued without prior
public comment because of the need to quickly respond to the pandemic. FDA
should assess its use of these policies to determine whether and how it will
implement them in future emergencies, and revise the policies to reflect lessons
learned during the COVID-19 pandemic. Specifically, FDA should assess the following
policies:
Developer notification policies: In March 2020, FDA began to allow certain test
developers to use validated tests before requesting EUA. FDA should assess
the potential use of notification policies in future emergencies, including the
appropriateness of additional safeguards to ensure adequate test performance
for tests that have not yet undergone full EUA review.
Prioritization policies: In May 2020, FDA began to adjust internal review
processes to address its increasing workload and to meet public health goals.
However, FDA did not finalize these revised review processes until later in
2020, leaving many developers confused as to the status of their EUA review.
FDA should determine parameters for reviewing EUA submissions, including
how to prioritize requests, how to communicate prioritization criteria to
developers, and how to best leverage the criteria to address FDA’s workload.
FDA should clearly communicate these parameters to developers.
Develop a suite of EUA templates for future emergencies
involving novel pathogens
Templates were useful tools in the pandemic that supported developers requesting
EUA for their tests. FDA recognizes the value in creating, in advance of an emergency,
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing
OEI-01-20-00380 Conclusion and Recommendations | 28
templates that can be more quickly available to developers. Rather than developing
new templates to support test developers as a novel pathogen emerges, as it did with
COVID-19, FDA should aim to develop a suite of templates that will be ready at the
start of an outbreak. FDA should adjust these as appropriate for the specifics of each
outbreak. FDA should develop templates for both pathogen types that are commonly
predicted to cause future outbreaks (e.g., from the WHO’s list of such pathogens) and
for various test types, such as rapid antigen tests.
Templates include key recommendations for how developers should validate their
tests to meet FDA’s requirements. When developing its suite of templates, FDA
should determine appropriate validation standards for each pathogen and test type.
This includes determining appropriate alternative validation materials for diagnostic
tests, such as synthetic material, which developers may need to use to address any
clinical sample access shortages. Such standards should include FDA’s criteria on
when it is appropriate to use these materials and what it expects for validating
diagnostic tests with these materials.
To ensure transparency with the developer community, FDA should consult with
stakeholders when developing templates, including validation recommendations, and
FDA should post templates on its website.
Expand CDRH’s existing device-tracking platform to facilitate
EUA submission and monitoring
For the period of our review, FDA managed its largest-ever volume of EUA requests
primarily over email. Test developers reported that this sometimes led to confusion,
including uncertainty about the status of their submissions. To support developers,
FDA should modify its existing Customer Collaboration Portal (CCP), which allows
developers to electronically track applications for devices submitted through certain
traditional marketing pathways. Developers could use the CCP’s existing features to
view the status of their requests, including their review milestones, rather than
reaching out to their reviewers for status updates. This would also reduce the burden
on FDA reviewers to communicate updates to developers. FDA could add a data
submission feature to this tool, which the CCP does not currently have. This would
automate and consolidate the EUA submission process into one tool, which would
help FDA and developers alike. While FDA has acknowledged the need to explore
opportunities to modernize and improve its EUA supporting tools, it has not
established any formal plans to do so.
Expand and improve resources for test developers on the EUA
process
FDA invested significant time and resources during the pandemic to support
inexperienced test developers. FDA should develop technical guidance and
educational material to ease some of its workload during any current and future
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OEI-01-20-00380 Conclusion and Recommendations | 29
emergency response and to ensure that these resources are available to developers as
early in an emergency as possible. To that end, FDA could develop EUA guidance
tailored specifically to address gaps in developers’ knowledge and experience, which
FDA identified during the COVID-19 pandemic. This guidance could, for example,
expand on FDA responses to FAQs from developers and provide updated instructions
for how to access and use templates. It could also fill in gaps that left some test
developers confused or frustrated, such as describing what FDA expects EUA
submission data to look like and explaining what developers can expect in terms of
communication from FDA.
FDA could also consider developing additional educational resources on the EUA
process. These could include training webinars or step-by-step guides on how to
request an EUA and how EUA requests are different from traditional marketing
pathways. By carrying out these activities in advance, FDA will reduce its workload
during emergencies as developers seek information on the EUA process.
In addition, FDA should continue the communication strategies that were successful
during the COVID-19 pandemic to apply to current and future emergencies, as
appropriate, particularly those that enhanced developer accessibility to FDA. These
include Town Halls, FDA email inboxes, and FAQs.
Establish formal communication channels between FDA and the
lab community, to be used in emergencies that require testing
During the COVID-19 pandemic, FDA would have benefited from more direct
communication with labs. For example, in February FDA was not aware that fewer
PHLs were testing than it believed. Prior to the next emergency, FDA should work
with key stakeholders in the lab community, such as APHL and the American Clinical
Laboratory Association (ACLA), to determine how to communicate during and in
advance of a public health emergency. FDA could consider creating regular forums
for connecting during emergencies, including setting up protocols and expectations
for when to initiate communications. During emergencies, FDA should use these
channels to maintain close contact with these stakeholders to ensure that it receives
direct information about emergency testing. In May 2022, FDA entered into a
memorandum of understanding (MOU) with CDC and lab stakeholders (including
APHL and ACLA).99 We urge FDA to use this MOU as a starting point in building a
collaborative relationship with CDC and the lab community before the next
emergency.
Work with Federal partners to implement lessons learned about
a national testing strategy outside the EUA process
Early challenges with CDC’s test rollout, clinical sample shortages, and an
overwhelming workload shaped FDA’s COVID-19 response. FDA should work closely
with Federal partners to assess what they can do now to avoid similar challenges in
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OEI-01-20-00380 Conclusion and Recommendations | 30
the future. This may be done by convening a formal panel of experts from each
agency involved in emergency response preparations, or developing individual
partnerships with one or more agencies to address specific challenges. At a
minimum, FDA should coordinate with appropriate Federal partners to:
Determine the feasibility of contracting with test manufacturers in advance of
the next emergency. This would ensure that qualified manufacturers are on
standby and could quickly produce well-designed, high-throughput tests at a
volume appropriate to meet the needs of each emergency. It would also
address manufacturers’ hesitancy early in the pandemic to invest in a test for a
novel disease, particularly without government incentives. Furthermore, it may
circumvent testing delays in case one test or manufacturer encounters
problems. FDA could seek a partnership with BARDA, which supports the
development of diagnostic tests during emergencies, to accomplish this.
Determine the feasibility of establishing a program to conduct all test
validation to support EUAs during an emergency. Rather than requiring each
developer to access its own validation materials, which may be limited early in
an emergency, the Federal government could develop a program to conduct
all validation during emergencies. Validation could occur on one or more
sites, potentially with Federal partners. FDA could help expand existing
partnerships with Federal agencies, such as NIH and CDC, that are currently
assessing COVID-19 serology and over-the-counter tests. FDA uses data
provided by these partners to inform its regulatory decisions. Such an
approach may also help address problems with developer validation.
Determine the feasibility of precertifying labs for emergency test development
and use. FDA should consider a pre-emergency, nationwide effort to certify
labs that are qualified to conduct emergency testing for emerging infectious
diseases. Certified labs would not need to submit an EUA request for tests
developed and used within that lab to respond to an emergency. Without so
many EUAs to review, FDA could devote more resources to supporting less
experienced test developers. Certified developers could begin using validated
tests immediately. FDA could seek a partnership with the Centers for
Medicare & Medicaid Services (CMS) to accomplish this, as CMS would have
insight into laboratory qualifications given its oversight role.
On the basis of its findings for the assessments recommended above, FDA should
implement all feasible recommendations.
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OEI-01-20-00380 Conclusion and Recommendations | 31
AGENCY COMMENTS AND OIG RESPONSE
FDA concurred with all six of our recommendations, as detailed below.
First, FDA concurred with our recommendation to assess and, as appropriate, revise
FDA guidance for test EUA submissions. We acknowledge that FDA has adapted its
regulatory approach to address the public’s testing needs throughout the COVID-19
pandemic. Given the importance of robust testing, especially in the early stages of a
pandemic, adapting lessons learned from this pandemic related to developer
notification and prioritization policies would position FDA to respond to current and
future pandemics. We appreciate FDA’s efforts thus far and look forward to the
updates on the status of its assessment and revisions, if appropriate, to guidance in its
Final Management Decision.
In concurring with our recommendation to develop a suite of EUA templates for
future emergencies involving novel pathogens, FDA stated that its COVID-19
templates helped facilitate important conversations with test developers. FDA also
reported that it has plans to engage test developers to create generic templates for
commonly anticipated pathogens. Having general templates on hand and ready for
the next novel pathogen can speed the EUA process and make it more efficient. In its
Final Management Decision, FDA should include an update on the status of the
templates.
FDA also concurred with our recommendation to expand CDRH’s existing device-
tracking platform to facilitate EUA submission and monitoring. We acknowledge
FDA’s efforts thus far to improve the EUA request process; adding tracking
functionality would streamline the process and add transparency for stakeholders.
Improving transparency, reducing duplicative efforts, and making the EUA submission
process more efficient will help ensure that tests are available for use faster when the
next novel pathogen emerges. FDA should detail in its Final Management Decision
the steps it has taken to add EUA requests to its submission tracker tool.
Next, FDA concurred with our recommendation to expand and improve resources for
test developers on the EUA process. In this report, we recommend that FDA continue
the communication strategies that were successful during the COVID-19 pandemic,
and FDA has indeed maintained these strategies. We look forward to FDA updates in
its Final Management Decision on its progress to expand and improve resources for
test developers, including technical guidance and educational material on the EUA
process.
FDA concurred with our recommendation to establish formal communication
channels between FDA and the lab community, to be used in emergencies that
require testing. In this report, we urged FDA to use the MOU that it entered into with
CDC and laboratory stakeholders as a starting point to build a collaborative
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OEI-01-20-00380 Agency Comments and OIG Response | 32
relationship with them and the lab community. FDA has already started to engage via
this MOU for its response to monkeypox. Continuing to build and strengthen
channels with the lab community will ensure that FDA maintains close contact with
lab community stakeholders during current and future emergencies that require
testing. We appreciate FDA’s efforts thus far and look forward to further updates on
the status of its efforts to establish these channels in its Final Management Decision.
Finally, FDA concurred with our recommendation to work with Federal partners to
implement lessons learned about a national testing strategy outside the EUA process.
We acknowledge that FDA has already communicated lessons learned through a
variety of avenues. We ask that FDA describe the steps that it is taking, which may
include convening a formal panel or developing individual partnerships, among other
potential approaches in its Final Management Decision.
For the full text of FDA’s comments, see the Appendix that follows this section.
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OEI-01-20-00380 Agency Comments and OIG Response | 33
APPENDIX
Appendix: Agency Comments
Following this page are the official comments from FDA.
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OEI-01-20-00380 Appendix | 34
FDA’s General Comments on on the OIG Draft Report, FDA Repeatedly
Adapted Emergency Use Authorization Policies to Address the Need for COVID-19 Testing
FDA appreciates the opportunity from the HHS Office of the Inspector General to
review and comment on this draft report.
General Comments
Recommendation 1
FDA should assess and, as appropriate, revise guidance for test EUA submissions.
FDA Response
FDA concurs that it should assess and, as appropriate, revise guidance for test EUA
submissions as the circumstances of PHEs warrant. Since the start of the COVID pandemic,
FDA adapted its regulatory approach to address the public’s testing needs, taking into
account benefits and risks of providing additional flexibilities under the circumstances at the
time. FDA continues to work closely with test developers to help them adjust as those needs
have changed. These efforts have helped support increased testing capacity overall and
broadened public access to rapid tests, including those purchased over the counter (OTC). In
addition to at-home diagnostic tests, FDA’s flexible policies have supported authorization of
a myriad of options, including molecular and antigen tests, as well as serology tests; Point-
Of-Care tests; home collection tests; multi-analyte tests that can detect both COVID-19 and
flu; tests using various sample types, including saliva; and screening tests with pooling and
serial testing. FDA made clear its review priorities, which were updated as appropriate. For
example, FDA prioritized review of EUA requests that increased national testing capacity
(e.g., for high throughput tests) or enhanced accessibility when needs indicated.
Prioritization for tests allowed FDA to best allocate limited resources, which became critical
as FDA faced an ever increasing and unprecedented number of EUA test submissions. The
Agency continues to receive about 100 EUA requests and pre-EUA submissions each month
for COVID-19 tests.
FDA also withdrew policies if and when the circumstances warranted. For example, when
clinical specimens became widely available, FDA updated its policy to recommend their use
in validation rather than contrived specimens. When FDA saw many serology tests coming
to market that did not perform as claimed, including those claiming to diagnose COVID-19,
the Agency discontinued its policy of no longer objecting to offering serology tests without
first receiving EUA authorization.
As FDA continues to support the nation’s response to COVID-19 and future PHEs, the
Agency will carefully evaluate which policies are appropriate to support development of
accurate and reliable tests and update them when circumstances warrant.
Recommendation 2
FDA should develop a suite of EUA templates for future emergencies involving novel
pathogens.
FDA Response
FDA concurs with OIG’s recommendation. FDA had also received a similar
recommendation from an independent study to develop a framework for how to conduct
validation of diagnostic tests for emerging pathogens in the setting of a declared PHE. FDA
plans to engage with test developers to establish generic templates for commonly anticipated
pathogens that may be adapted for potential future outbreaks, as well as a framework for
conducting appropriate validation under different circumstances, to speed the availability of
future in vitro diagnostic (IVD) tests. FDA has noted these plans publicly here: Emergency
Use Authorization of COVID-19 Tests: Independent Assessment of the FDA’s Response |
FDA. In fact, stakeholders have reached out to engage with FDA, and we have received
helpful feedback that we have already incorporated into our validation templates.
COVID-19 templates provided recommendations for test validation and a fill-in-the-blank
form to streamline the paperwork and make it easier for developers to provide information
in support of EUA requests. Since providing the first template in January 2020, FDA has
been in daily contact with test developers to answer questions and help them through the
EUA process. FDA had as many as ten posted templates and continues to update, add,
combine, and remove templates as the science evolves and as necessary to support COVID-
19 test developers. As of August 8, 2022, these templates have received over 6039 hits from
those visiting FDA’s website.
FDA notes that its templates provide recommendations based on FDA’s experience, the state
of the science, availability of validation material or other components, and the regulatory
criteria to issue an EUA. Our recommendations are just that — recommendations. FDA is
always open to alternative proposals from developers and will continue to consider those.
More significant trade-offs in test accuracy may be appropriate where the need for
availability and fast results is not being met. We found during the COVID-19 pandemic that
our templates helped to facilitate these important conversations with developers and believe
they will be critical in the future when we are faced with pathogens, both well-known and
novel.
Recommendation 3
FDA should expand the FDA Center for Devices and Radiological Health’s existing device-
tracking platform to facilitate EUA submission and monitoring.
FDA Response:
FDA concurs with OIG’s recommendation and notes that this is also consistent with a
recommendation made by an independent study: Emergency Use Authorization of COVID-
19 Tests: Independent Assessment of the FDA’s Response | FDA. In an effort to provide
transparency, efficiency, and predictability for test developers, , FDA has implemented
improvements and streamlined its EUA review processes. From March 2020 to present,
CDRH has identified IT system needs and implemented several improvements to facilitate
EUA request submission tracking, including updating current systems to improve the
tracking and management of EUA review and providing electronic submission (vs. mailing)
capabilities for EUA submissions through our CDRH Submission Portal.
Page 2 of 5
FDA plans to continue IT improvements that will streamline processes and improve
transparency for sponsors, including adding EUA requests and other submissions to its
submission tracker, though this will ultimately depend on resources.
FDA also notes that CDRH initiated a Digital Transformation Initiative in Fiscal Year (FY)
2016, which is ongoing. This initiative focuses on providing better IT infrastructures,
technology solutions, and data to help both internal and external stakeholders across all
regulatory programs. The goal is to improve transparency, reduce duplicative efforts, create
an integrated environment, and help ensure that data are organized, curated properly, and
accurate for decision making. This ongoing effort will help CDRH better track future EUA
requests as well as provide better platforms for interacting with medical device sponsors
when questions arise about their submissions.
.
Recommendation 4
FDA should expand and improve resources for test developers on the EUA process.
FDA Response
FDA concurs with OIG’s recommendations. FDA had also received a related
recommendation from an independent study to develop a framework for how to conduct
validation of diagnostic tests for emerging pathogens in the setting of a declared PHE. 1 2 As
noted in one of our previous responses, FDA plans to continue strengthening
communication strategies and tools that have proven effective during the COVID-19 PHE,
including town halls, webinars, a telephone hotline and email boxes for stakeholder
inquiries, templates, and interactions with professional and trade organizations, and has
already taken additional steps to do so.
As OIG’s report acknowledges, FDA entered into a memorandum of understanding (MOU)
with CDC and laboratory stakeholders (including APHL and ACLA) in May 2022, a formal
step in further building collaborative relationships with the lab community. FDA is already
fully engaged with CDC and developers under this MOU with respect to Monkeypox.
Specifically, FDA is providing regulatory as well as clinical and technical diagnostics
expertise to facilitate discussions about planning and implementing surge capacity for
diagnostic testing. The Agency believes that even in this short time, the MOU has been
helpful, particularly for allowing the USG to hear directly from laboratory professional
associations and large commercial laboratories regarding:
a. their willingness to test,
b. what they are hearing in their interactions,
c. where their pain points are,
d. barriers to getting involved in any kind of response, and
e. suggestions on next steps from their perspectives
In addition, FDA continues its regular town hall meetings for COVID-19 test developers and
has started to include Monkeypox test announcements and updates during these sessions.
1
Emergency Use Authorization of COVID-19 Tests: Independent Assessment of the FDA’s Response | FDA
2
Deliverable 15: Emergency Use Authorization Assessment - Final Report (fda.gov)
Page 3 of 5
The Agency also planned with CDC and participated in a Laboratory Biosafety Townhall on
June 24, 2022, which was a collaboration with clinical and public health laboratory partners
and instrument manufacturers discussing testing in laboratories during emergencies. 3
These are just a few steps FDA has taken, in addition to incorporating stakeholder feedback
into our templates.
Recommendation 5
FDA should establish formal communication channels between FDA and the lab
community, to be used in emergencies that require testing.
FDA Response
FDA concurs with OIG’s recommendations. FDA had also received a related
recommendation from an independent study to develop a framework for how to conduct
validation of diagnostic tests for emerging pathogens in the setting of a declared PHE. 4 5 As
noted in one of our previous responses, FDA plans to continue strengthening
communication strategies and tools that have proven effective during the COVID-19 PHE,
including town halls, webinars, a telephone hotline and email boxes for stakeholder
inquiries, templates, and interactions with professional and trade organizations, and has
already taken additional steps to do so.
As OIG’s report acknowledges, FDA entered into a memorandum of understanding (MOU)
with CDC and laboratory stakeholders (including APHL and ACLA) in May 2022, a formal
step in further building collaborative relationships with the lab community. FDA is already
fully engaged with CDC and developers under this MOU with respect to Monkeypox.
Specifically, FDA is providing regulatory as well as clinical and technical diagnostics
expertise to facilitate discussions about planning and implementing surge capacity for
diagnostic testing. The Agency believes that even in this short time, the MOU has been
helpful, particularly for allowing the USG to hear directly from laboratory professional
associations and large commercial laboratories regarding:
a. their willingness to test,
b. what they are hearing in their interactions,
c. where their pain points are,
d. barriers to getting involved in any kind of response, and
e. suggestions on next steps from their perspectives
In addition, FDA continues its regular town hall meetings for COVID-19 test developers and
has started to include Monkeypox test announcements and updates during these sessions.
The Agency also planned with CDC and participated in a Laboratory Biosafety Townhall on
June 24, 2022, which was a collaboration with clinical and public health laboratory partners
and instrument manufacturers discussing testing in laboratories during emergencies. 6
3
CDC Town Hall Meeting on Laboratory Biosafety - Use of Laboratory Instruments, June 24, 2022
4
Emergency Use Authorization of COVID-19 Tests: Independent Assessment of the FDA’s Response | FDA
5
Deliverable 15: Emergency Use Authorization Assessment - Final Report (fda.gov)
6
CDC Town Hall Meeting on Laboratory Biosafety - Use of Laboratory Instruments, June 24, 2022
Page 4 of 5
These are just a few steps FDA has taken, in addition to incorporating stakeholder feedback
into our templates.
Recommendation 6
FDA should work with Federal partners to implement lessons learned about a national
testing strategy that go beyond the EUA process.
FDA Response
FDA concurs with OIG’s recommendation. We have already communicated lessons learned
through a variety of avenues, 7 8 9including the publication of two peer-reviewed articles 10 11
and will continue to work with Federal partners to try to implement them.
7
Bending The Arc Of COVID-19 Test Development To Increase Access And Ensure Reliability—
Now And In The Future | Health Affairs
8
South Korea’s Implementation Of A COVID-19 National Testing Strategy | Health Affairs
9
South Korea's Response to COVID-19: Focus on Testing Strategy and Lessons Learned (fda.gov)
10
Covid-19 Molecular Diagnostic Testing — Lessons Learned | NEJM
11
The FDA’s Experience with Covid-19 Antibody Tests | NEJM
Page 5 of 5
ACKNOWLEDGMENTS AND CONTACT
Elizabeth Sandefer served as the team leader for this study. Others in the Office of
Evaluation and Inspections who conducted the study include Sarah Hijaz and Malaena
Taylor. Office of Evaluation and Inspections headquarters staff who provided support
include Althea Hosein and Michael Novello.
This report was prepared under the direction of Joyce Greenleaf, Regional Inspector
General for Evaluation and Inspections in the Boston regional office, and Danielle
Fletcher, Deputy Regional Inspector General.
Contact
To obtain additional information concerning this report, contact the Office of Public
Affairs at Public.Affairs@oig.hhs.gov. OIG reports and other information can be found
on the OIG website at oig.hhs.gov.
Office of Inspector General
U.S. Department of Health and Human Services
330 Independence Avenue, SW
Washington, DC 20201
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OEI-01-20-00380 Acknowledgements and Contact | 40
ABOUT THE OFFICE OF INSPECTOR GENERAL
The mission of the Office of Inspector General (OIG), as mandated by Public Law
95-452, as amended, is to protect the integrity of the Department of Health and
Human Services (HHS) programs, as well as the health and welfare of beneficiaries
served by those programs. This statutory mission is carried out through a nationwide
network of audits, investigations, and inspections conducted by the following
operating components:
The Office of Audit Services (OAS) provides auditing services for HHS,
either by conducting audits with its own audit resources or by overseeing audit work
done by others. Audits examine the performance of HHS programs and/or its
grantees and contractors in carrying out their respective responsibilities and are
intended to provide independent assessments of HHS programs and operations.
These audits help reduce waste, abuse, and mismanagement and promote economy
and efficiency throughout HHS.
The Office of Evaluation and Inspections (OEI) conducts national
evaluations to provide HHS, Congress, and the public with timely, useful, and reliable
information on significant issues. These evaluations focus on preventing fraud, waste,
or abuse and promoting economy, efficiency, and effectiveness of departmental
programs. To promote impact, OEI reports also present practical recommendations
for improving program operations.
The Office of Investigations (OI) conducts criminal, civil, and administrative
investigations of fraud and misconduct related to HHS programs, operations, and
beneficiaries. With investigators working in all 50 States and the District of Columbia,
OI utilizes its resources by actively coordinating with the Department of Justice and
other Federal, State, and local law enforcement authorities. The investigative efforts
of OI often lead to criminal convictions, administrative sanctions, and/or civil
monetary penalties.
The Office of Counsel to the Inspector General (OCIG) provides
general legal services to OIG, rendering advice and opinions on HHS programs and
operations and providing all legal support for OIG’s internal operations. OCIG
represents OIG in all civil and administrative fraud and abuse cases involving HHS
programs, including False Claims Act, program exclusion, and civil monetary penalty
cases. In connection with these cases, OCIG also negotiates and monitors corporate
integrity agreements. OCIG renders advisory opinions, issues compliance program
guidance, publishes fraud alerts, and provides other guidance to the health care
industry concerning the anti-kickback statute and other OIG enforcement authorities.
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing
OEI-01-20-00380 About the Office of Inspector General | 41
ENDNOTES
1 The virus that causes COVID-19 is called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). For readability, this
report will refer to both the illness and the virus as COVID-19.
2 Michelle L. Holshue, Chas BeBolt, Scott Lindquist, Kathy H. Lofy, John Wiesman, Hollianne Bruce, Christopher Spitters, et al.,
“First Case of 2019 Novel Coronavirus in the United States,” New England Journal of Medicine, March 5, 2020, 382: 929-936.
3 Although WHO did not declare COVID-19 a pandemic until March, for readability, this report will refer to the entire time
period after COVID-19 emerged as ”the COVID-19 pandemic” or “the pandemic.”
4 World Health Organization, Timeline: WHO’s COVID-19 response. Accessed at
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/interactive-timeline# on April 11, 2022.
5 CDC, Principles of Epidemiology in Public Health Practice. Accessed at
https://www.cdc.gov/csels/dsepd/ss1978/lesson1/section11.html on October 4, 2021.
6 CDC, COVID Data Tracker. Accessed at https://covid.cdc.gov/covid-data-tracker/#datatracker-home on May 25, 2022.
7 FDA, Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised): Guidance for Clinical
Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff, May 11, 2020. Accessed at
https://www.fda.gov/media/135659/download on September 21, 2021.
8 The World Health Organization first dispatched a diagnostic test for COVID-19 to its Regional Offices on February 2, 2020.
World Health Organization, Timeline: WHO’s COVID-19 response. Accessed at
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/interactive-timeline#event-46 on February 16, 2022.
9 FDA, FDA Announced Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures, January 27, 2020.
Accessed at https://www.fda.gov/news-events/press-announcements/fda-announces-key-actions-advance-development-
novel-coronavirus-medical-countermeasures on September 21, 2021.
10 21 U.S.C. § 360bbb-3.
11 21 CFR § 860.7.
12 FDA, FAQs on Emergency Use Authorizations (EUAs) for Medical Devices During the COVID-19 Pandemic. Accessed at
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-
devices/faqs-emergency-use-authorizations-euas-medical-devices-during-covid-19-pandemic on December 22, 2021.
13 The Secretary may also declare that circumstances exist to justify EUA for certain products based on significant potential of
an emergency, without the declaration of a public health emergency. For the purposes of this report, we will use the term
“emergency” to include public health emergencies.
14 21 U.S.C. § 360bbb-3.
15 FDA, Emergency Use Authorization. Accessed at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-
regulatory-and-policy-framework/emergency-use-authorization on March 20, 2020.
16 Federal Register, Determination of Public Health Emergency, February 7, 2020. Accessed at
https://www.federalregister.gov/documents/2020/02/07/2020-02496/determination-of-public-health-emergency on April 11,
2022.
17 21 U.S.C. § 360bbb-3.
18 FDA, Emergency Use Authorization. Accessed at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-
regulatory-and-policy-framework/emergency-use-authorization on March 20, 2020.
19 Test developers may request FDA approval or clearance to market and use their product. Test developers may seek approval
or clearance during emergencies or nonemergencies.
20 21 CFR § 860.7.
21 FDA, Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised): Guidance for Clinical
Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff, May 11, 2020. Accessed at
https://www.fda.gov/media/135659/download?fbclid=IwAR3QjmFqN2BMNJq4IFCfDOnpogvsdsJdwM4pJFE1E1ltqNNRJ8zBjFUS
OSQ on October 5, 2021.
22 FDA, Emergency Use Authorization of Medical Products and Related Authorities, January 2017. Accessed at Emergency Use
Authorization of Medical Products (fda.gov) on September 21, 2021.
23 21 U.S.C. § 360bbb-3.
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing
OEI-01-20-00380 Endnotes | 42
24 21 CFR § 860.7.
25 FDA, Emergency Use Authorization of Medical Products and Related Authorities: Guidance for Industry and Other Stakeholders,
January 2017. Accessed at https://www.fda.gov/media/97321/download on May 25, 2022.
26 Jeffrey Shuren, “FDA’s Ongoing Work to Support and Advance COVID-19 Diagnostic Test Accuracy and Availability.”
Accessed at https://www.fda.gov/news-events/fda-voices/fdas-ongoing-work-support-and-advance-covid-19-diagnostic-test-
accuracy-and-availability on September 23, 2021.
27 Project BioShield Act of 2004, P.L. 108-276 July 21, 2004.
28 FDA, Emergency Use Authorizations for Medical Devices. Accessed at https://www.fda.gov/medical-devices/emergency-
situations-medical-devices/emergency-use-authorizations-medical-devices#coronavirus2013 on July 9, 2020.
29 The Medical Device Amendments of 1976, P.L. 94-295, are codified largely in ch. V of the FFDCA, §§ 501–573, 21 U.S.C. §§
351–360ccc-2.
30 FDA, How to Determine If Your Product Is a Medical Device. Accessed at https://www.fda.gov/medical-devices/classify-your-
medical-device/how-determine-if-your-product-medical-device on September 29, 2021.
31 FDA, Center for Devices and Radiological Health. Accessed at https://www.fda.gov/about-fda/fda-organization/center-
devices-and-radiological-health on June 13, 2022.
32 21 U.S.C. § 360bbb-3.
33 FDA, FDA Virtual Town Hall Series- Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests, September
23, 2020. Accessed at https://www.fda.gov/media/142511/download on October 7, 2021.
34FDA, How to Submit a Pre-Emergency Use Authorization for In vitro Diagnostics to FDA. Accessed at
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/how-submit-pre-
eua-vitro-diagnostics-fda on July 6, 2020.
35 FDA, Emergency Use Authorization of Medical Products and Related Authorities: Guidance for Industry and Other Stakeholders,
January 2017. Accessed at https://www.fda.gov/media/97321/download on May 25, 2022.
36 FDA, Emergency Use Authorization of Medical Products and Related Authorities: Guidance for Industry and Other Stakeholders,
January 2017. Accessed at https://www.fda.gov/media/97321/download on May 25, 2022.
37 FDA, Emergency Use Authorization of Medical Products and Related Authorities: Guidance for Industry and Other Stakeholders,
January 2017. Accessed at https://www.fda.gov/media/97321/download on May 25, 2022.
38 FDA, Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised): Guidance for Developers and
Food and Drug Administration Staff, November 15, 2021. Accessed at https://www.fda.gov/media/135659/download on May
27, 2022.
39 21 U.S.C. § 360bbb-3.
40 FDA, Emergency Use Authorization of Medical Products and Related Authorities: Guidance for Industry and Other Stakeholders,
January 2017. Accessed at https://www.fda.gov/media/97321/download on July 7, 2020.
41 21 U.S.C. § 360bbb-3.
42 FDA, Emergency Use Authorization of Medical Products and Related Authorities: Guidance for Industry and Other Stakeholders,
January 2017. Accessed at https://www.fda.gov/media/97321/download on May 25, 2022.
43 FDA has also authorized other tests for the medical management of patients with COVID-19, but those are excluded from
this study.
44 FDA, Important Information on the Use of Serological (Antibody) Tests for COVID-19 – Letter to Health Care Providers, April 17,
2020. Accessed at: https://www.fda.gov/medical-devices/letters-health-care-providers/important-information-use-serological-
antibody-tests-covid-19-letter-health-care-providers on September 21, 2021.
45 FDA, Coronavirus (COVID-19) Update: Daily Roundup May 29, 2020, May 29, 2020. Accessed at https://www.fda.gov/news-
events/press-announcements/coronavirus-covid-19-update-daily-roundup-may-29-2020 on September 24, 2021.
46 FDA, FDA Roundup: May 3, 2022. Accessed at https://www.fda.gov/news-events/press-announcements/fda-roundup-may-3-
2022 on May 3, 2022.
47 Eighty-four of our 237 respondents developed more than one test for COVID-19, and many of these developers applied for
EUA for more than one test. To avoid confusion, our survey questions specifically asked about each developer’s first
experience applying for EUA for a COVID-19 test.
48 CDC, Shipping of CDC 2019 Novel Coronavirus Diagnostic Test Kits Begins, February 6, 2020. Accessed at
https://www.cdc.gov/media/releases/2020/p0206-coronavirus-diagnostic-test-kits.html on December 9, 2021.
49 Public health labs work with CDC during emergencies to conduct clinical diagnostic testing and disease surveillance, among
other activities.
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing
OEI-01-20-00380 Endnotes | 43
50 FDA, Coronavirus (COVID-19) Update: FDA expedited review of diagnostic tests to combat COVID-19, March 30, 2020.
Accessed at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-expedites-review-
diagnostic-tests-combat-covid-19 on October 18, 2021.
51 Document submitted to the Homeland Security & Governmental Affairs Committee (2021).
52 Testimony from Robert Redfield to the House Foreign Affairs Subcommiitee on Asia, the Pacific, and Nonproliferation.
Coronavirus Disease 2019: The U.S. and International Response. Accessed at
https://www.cdc.gov/washington/testimony/2020/t20200127.htm on March 3, 2022.
53 Letter to Grace Kubin, Director, Laboratory Services Section, Texas Department of State Health Services, and Scott J. Becker,
Chief Executive Officer, Association of Public Health Laboratories, from Stephen M. Hahn, Commissioner, FDA, February 26,
2020. Accessed at https://context-cdn.washingtonpost.com/notes/prod/default/documents/1bbf4d0e-8c11-4126-b3af-
24a0575c0012/note/076de12e-172d-49e5-8c50-883688f9c999. on August 11, 2022.
54 FDA, Coronavirus (COVID-19) Update: FDA Issues New Policy to Help Expedite Availability of Diagnostics, February 29, 2020.
Accessed at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-
update-fda-issues-new-policy-help-expedite-availability-diagnostics on December 27, 2021.
55 FDA subsequently received letters from the New York State Department of Health, the New York City Department of Health
and Mental Hygiene, the American Association for Clinical Chemistry, and the American Society for Microbiology, asking FDA
to consider taking steps to allow certain labs to begin testing without EUA.
56
FDA reduced the number of positive specimens to the smallest number that would still statistically demonstrate acceptable
test performance.
57 FDA, Accelerated Emergency Use Authorization Templates for SARS-CoV-2 (COVID-19) Molecular Testing of Respiratory
Specimens in CLIA Certified High-Complexity Laboratories, March 7, 2020. Accessed at https://asm.org/ASM/media/Article-
Images/EUA-Covid19-Template.pdf on April 11, 2022.
58 Jeffrey Shuren and Timothy Stenzel, “Covid-19 Molecular Diagnostic Testing – Lessons Learned,” The New England Journal of
Medicine, October 22, 2020, 383: e97.
59 FDA, Accelerated Emergency Use Authorization Templates for SARS-CoV-2 (COVID-19) Molecular Testing of Respiratory
Specimens in CLIA Certified High-Complexity Laboratories, March 7, 2020. Accessed at https://asm.org/ASM/media/Article-
Images/EUA-Covid19-Template.pdf on April 11, 2022.
60 Jeffrey Shuren and Timothy Stenzel, “Covid-19 Molecular Diagnostic Testing – Lessons Learned,” The New England Journal of
Medicine, October 22, 2020, 383: e97.
61 FDA, Coronavirus (COVID-19) Update: Daily Roundup, March 23, 2020. Accessed at https://www.fda.gov/news-events/press-
announcements/coronavirus-covid-19-update-daily-roundup on December 21, 2021.
62 FDA, Coronavirus (COVID-19) Update: Daily Roundup May 11, 2020, May 11, 2020. Accessed at https://www.fda.gov/news-
events/press-announcements/coronavirus-covid-19-update-daily-roundup-may-11-2020 on December 27, 2021.
63 The Coronavirus Aid, Relief, and Economic Security Act requires insurance payers to pay for EUA authorized tests as well as
tests for which the developer requested or intends to request EUA. It is unclear why insurance payers did not pay for the
developer’s test in this instance.
64 P.L. 109–148.
65 As of November 2021, eight States and Puerto Rico notified FDA that they are operating under this flexibility. Labs in these
States do not need to seek EUA or engage with FDA; thus, we were not able to assess the effect on testing for States that
accepted this policy.
66 FDA, Coronavirus (COVID-19) Update: FDA Issues New Policy to Help Expedite Availability of Diagnostics, February 29, 2020.
Accessed at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-
update-fda-issues-new-policy-help-expedite-availability-diagnostics on December 27, 2021.
67 FDA, Coronavirus (COVID-19) Update: FDA Provides More Regulatory Relief During Outbreak, Continues to Help Expedite
Availability of Diagnostics, March 16, 2020. Accessed at https://www.fda.gov/news-events/press-announcements/coronavirus-
covid-19-update-fda-provides-more-regulatory-relief-during-outbreak-continues-help on December 27, 2020.
68 Anand Shah and Jeffrey Shuren, Insight into FDA’s Revised Policy on Antibody Tests: Prioritizing Access and Accuracy, May 4,
2020. Accessed at https://www.fda.gov/news-events/fda-voices/insight-fdas-revised-policy-antibody-tests-prioritizing-access-
and-accuracy on December 27, 2021.
69 Anand Shah and Jeffrey Shuren, Insight into FDA’s Revised Policy on Antibody Tests: Prioritizing Access and Accuracy, May 4,
2020. Accessed at https://www.fda.gov/news-events/fda-voices/insight-fdas-revised-policy-antibody-tests-prioritizing-access-
and-accuracy on December 27, 2021.
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing
OEI-01-20-00380 Endnotes | 44
70 Jeffrey Shuren and Timothy Stenzel, “The FDA’s Experience with Covid-19 Antibody Tests,” The New England Journal of
Medicine, February 18, 2021, 384:592-594.
71 Jeffrey Shuren and Timothy Stenzel, “The FDA’s Experience with Covid-19 Antibody Tests,” The New England Journal of
Medicine, February 18, 2021, 384:592-594.
72 These are labs certified as high-complexity under the Clinical Laboratory Improvement Amendments (CLIA).
73 FDA, Coronavirus (COVID-19) Update: FDA Provides More Regulatory Relief During Outbreak, Continues to Help Expedite
Availability of Diagnostics, March 16, 2020. Accessed at https://www.fda.gov/news-events/press-announcements/coronavirus-
covid-19-update-fda-provides-more-regulatory-relief-during-outbreak-continues-help on December 27, 2020.
74 Jeffrey Shuren and Timothy Stenzel, “The FDA’s Experience with Covid-19 Antibody Tests,” The New England Journal of
Medicine, February 18, 2021, 384:592-594.
75 Jeffrey Shuren and Timothy Stenzel, “The FDA’s Experience with Covid-19 Antibody Tests,” The New England Journal of
Medicine, February 18, 2021, 384:592-594.
76 The Coronavirus Aid, Relief, and Economic Security Act later extended FDA’s authority to seek information about potential
supply shortages.
77 Jeffrey Shuren and Timothy Stenzel, “Covid-19 Molecular Diagnostic Testing – Lessons Learned,” The New England Journal of
Medicine, October 22, 2020, 383: e97.
78 Jeffrey Shuren and Timothy Stenzel, “Covid-19 Molecular Diagnostic Testing – Lessons Learned,” The New England Journal of
Medicine, October 22, 2020, 383: e97.
79 Jeffrey Shuren and Timothy Stenzel, “The FDA’s Experience with Covid-19 Antibody Tests,” The New England Journal of
Medicine, February 18, 2021, 384:592-594.
80 Sheila Kaplan, “FDA Orders Companies to Submit Antibody Test Data,” The New York Times, May 4, 2020. Accessed at
https://www.nytimes.com/2020/05/04/health/fda-antibody-tests-
coronavirus.html?utm_campaign=pharmalittle&utm_source=hs_email&utm_medium=email&utm_content=87429
897&_hsenc=p2ANqtz-9gWqHfGuypBVzNZbMBhjbNBl_qTPV3lwDtk7Y9eXG0l5lbbs4JQW4lfe9Ej--
R0foxQzLAPZzhjVyvfXnvHDNNWJi1Bg&_hsmi=87429897 on June 8, 2020.
81 FDA, Coronavirus (COVID-19) Update: FDA Provides More Regulatory Relief During Outbreak, Continues to Help Expedite
Availability of Diagnostics, March 16, 2020. Accessed at https://www.fda.gov/news-events/press-announcements/coronavirus-
covid-19-update-fda-provides-more-regulatory-relief-during-outbreak-continues-help on December 27, 2020.
82 Jeffrey Shuren and Timothy Stenzel, “The FDA’s Experience with Covid-19 Antibody Tests,” The New England Journal of
Medicine, February 18, 2021, 384:592-594.
83 Jeffrey Shuren and Timothy Stenzel, “The FDA’s Experience with Covid-19 Antibody Tests,” The New England Journal of
Medicine, February 18, 2021, 384:592-594.
84 Jeffrey Shuren and Timothy Stenzel, “The FDA’s Experience with Covid-19 Antibody Tests,” The New England Journal of
Medicine, February 18, 2021, 384:592-594.
85 FDA, Important Information on the Use of Serological (Antibody) Tests for COVID-19- Letter to Health Care Providers, April 17,
2020. Accessed at https://www.fda.gov/medical-devices/letters-health-care-providers/important-information-use-serological-
antibody-tests-covid-19-letter-health-care-providers on September 24, 2021.
86 FDA, Coronavirus (COVID-19) Update: Serological Test Validation and Education Efforts, April 18, 2020. Accessed at
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-serological-test-validation-and-
education-efforts on October 21, 2021.
87 Jeffrey Shuren and Timothy Stenzel, “The FDA’s Experience with Covid-19 Antibody Tests,” The New England Journal of
Medicine, February 18, 2021, 384:592-594.
88 FDA, EUA Authorized Serology Test Performance. Accessed at https://www.fda.gov/medical-devices/coronavirus-disease-
2019-covid-19-emergency-use-authorizations-medical-devices/eua-authorized-serology-test-performance on October 21,
2021.
89 Anand Shah and Jeffrey Shuren, Insight into FDA’s Revised Policy on Antibody Tests: Prioritizing Access and Accuracy, May 4,
2020. Accessed at https://www.fda.gov/news-events/fda-voices/insight-fdas-revised-policy-antibody-tests-prioritizing-access-
and-accuracy on December 27, 2021.
90 Anand Shah and Jeffrey Shuren, Insight into FDA’s Revised Policy on Antibody Tests: Prioritizing Access and Accuracy, May 4,
2020. Accessed at https://www.fda.gov/news-events/fda-voices/insight-fdas-revised-policy-antibody-tests-prioritizing-access-
and-accuracy on December 27, 2021.
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing
OEI-01-20-00380 Endnotes | 45
91 FDA, Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised), May 4, 2020. Accessed at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-coronavirus-disease-2019-tests-during-
public-health-emergency-revised on October 5, 2021.
92 FDA, Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2. Accessed at
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/notifications-and-emergency-use-
authorizations-faqs-testing-sars-cov-2 on October 21, 2021.
93 FDA, Coronavirus (COVID-19) Update: FDA Provides Promised Transparency for Antibody Tests, May 21, 2020. Accessed at
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-promised-transparency-
antibody-tests on October 21, 2021.
94 FDA, Import Alerts. Accessed at https://www.fda.gov/industry/actions-enforcement/import-alerts on June 29, 2022.
95 FDA, Historical Information about Device Emergency Use Authorizations. Accessed at https://www.fda.gov/medical-
devices/emergency-use-authorizations-medical-devices/historical-information-about-device-emergency-use-authorizations on
December 27, 2021.
96 FDA, Coronavirus (COVID-19) Update: January 29, 2021. Accessed at https://www.fda.gov/news-events/press-
announcements/coronavirus-covid-19-update-january-29-2021 on December 27, 2021.
97 FDA, Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised): Guidance for Clinical
Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff. Accessed at
https://www.fda.gov/media/135659/download on September 21, 2021.
98 FDA’s EUA authority includes broad flexibility to set prioritization criteria for reviewing EUA requests. For example, FDA may
prioritize certain tests for review to meet a public health goal such as maximizing capacity to process tests. See FDA,
Emergency Use Authorization of Medical Products and Related Authorities: Guidance for Industry and Other Stakeholders, January
2017. Accessed at https://www.fda.gov/media/97321/download on October 7, 2021.
99 MOU 225-22-020. Accessed at https://www.fda.gov/about-fda/domestic-mous/mou-225-22-020 on June 28, 2022.
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing
OEI-01-20-00380 Endnotes | 46
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