GAO-22-104266, COVID-19: FDA Took Steps to Help Make Tests Available; Policy for Future Public Health Emergencies Needed
- Issuer
- Government Accountability Office
- Document type
- Report
- Date
- 2021-09-30
Summary
GAO-22-104266, a Government Accountability Office report to congressional addressees dated May 12, 2022, titled COVID-19: FDA Took Steps to Help Make Tests Available; Policy for Future Public Health Emergencies Needed. The report examines FDA's actions to make COVID-19 tests available, the number of tests it authorized or for which it exercised enforcement discretion, and how it monitors tests after they are available. It reports that FDA authorized 412 tests and that, as of September 30, 2021, it had exercised enforcement discretion for 370 unauthorized tests. By December 31, 2021, FDA had received more than 18,000 reports of performance problems. GAO recommends that FDA develop a policy on when to begin and end enforcement discretion for unauthorized tests in future public health emergencies, and states that the Department of Health and Human Services concurred.
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
United States Government Accountability Office
Report to Congressional Addressees
COVID-19
May 2022
FDA Took Steps to
Help Make Tests
Available; Policy for
Future Public Health
Emergencies Needed
GAO-22-104266
May 2022
COVID-19
FDA Took Steps to Help Make Tests Available; Policy
for Future Public Health Emergencies Needed
Highlights of GAO-22-104266, a report to
congressional addressees
Why GAO Did This Study What GAO Found
Diagnostic testing for COVID-19 is The Food and Drug Administration (FDA) took several actions aimed at
critical to tracking the virus, informing increasing the availability of COVID-19 tests in the United States. This included
treatment, and suppressing granting emergency use authorizations (EUA) for more than 400 COVID-19 tests
transmission. However, because and sample collection devices by the end of 2021 (see figure). In a public health
COVID-19 is caused by a novel virus, emergency, FDA may grant EUAs to temporarily allow the use of unapproved
no test existed at the beginning of the medical products, provided there is evidence that the product may be effective
pandemic. Typically, medical devices, and that the known and potential benefits outweigh known and potential risks.
such as diagnostic tests, must be FDA also exercised enforcement discretion for certain COVID-19 tests —that is,
approved or cleared by FDA before
it did not object to laboratories’ use of these COVID-19 tests before FDA had
they can be offered. However, FDA’s
authorized them; this did not apply to tests that could be used at home. FDA’s
EUA authority requires a lower level of
evidence than the effectiveness
use of enforcement discretion helped increase test availability early in the
standard normally required for FDA pandemic.
product approval; therefore, it can help Cumulative Number of COVID-19 Tests and Sample Collection Devices Authorized by FDA for
tests become available in a shorter Emergency Use, 2020-2021
amount of time. Test developers
submit EUA requests to FDA that
include data on a test’s performance,
and FDA reviews the data to determine
whether to grant an EUA.
GAO was asked to review FDA’s
oversight of tests for COVID-19. This
report examines, among other things,
1) the actions FDA took to help make
COVID-19 tests available for use, 2)
the number of tests FDA authorized
and those for which it exercised As of September 30, 2021, FDA had exercised its enforcement discretion for 370
enforcement discretion, and 3) FDA’s tests. Test developers had submitted EUA requests for these tests, but FDA had
monitoring of these tests after they not yet reviewed them. FDA officials told GAO they had concerns about the lack
were available for use. GAO reviewed of review for these unauthorized tests, and as the number grew, the risks of this
agency documentation, and policy began to outweigh the benefits. Nevertheless, it was not until November
interviewed FDA and associations that 2021 that FDA updated its COVID-19 test policy with the intention of phasing out
represent test developers. the agency’s use of enforcement discretion and reducing the number of
unauthorized tests. However, FDA has no policy for when it would begin and end
What GAO Recommends exercising enforcement discretion for the use of unauthorized tests in a future
GAO recommends that FDA develop a public health emergency. Without such a policy, if FDA were to exercise similar
policy for the use of enforcement enforcement discretion in the future, the agency could face the risk that tests with
discretion regarding unauthorized tests uncertain accuracy and reliability could be available for use for an extended
in future public health emergencies. period of time, even when a sufficient number of authorized tests are available.
This policy should include the This could hamper an effective response and recovery during a crisis.
conditions under which FDA would
begin and end the use of such FDA monitors the performance of all COVID-19 tests—whether granted an EUA
discretion. The Department of Health or not—through reports of performance problems submitted to FDA by test
and Human Services concurred with developers, health care providers, and consumers. According to FDA, this
our recommendation. includes reports of false positive or false negative test results. By December 31,
View GAO-22-104266. For more information,
2021, FDA had received more than 18,000 such reports for COVID-19 tests and
contact Mary Denigan-Macauley at (202) 512- took action to address identified problems. For example, FDA issued 10 letters to
7144 or DeniganMacauleyM@gao.gov. clinical laboratory staff and health care providers to inform them of safety
concerns about COVID-19 tests.
United States Government Accountability Office
Contents
Letter 1
Background 6
FDA Took Various Actions to Help Increase the Availability of
COVID-19 Tests 10
FDA Authorized 412 Tests and Exercised Enforcement Discretion
for 370 Unauthorized Tests 20
FDA Monitors Reports of Performance Problems with COVID-19
Tests and Takes Action to Address Them 25
Conclusions 34
Recommendation for Executive Action 34
Agency Comments 34
Appendix I Additional FDA Actions to Help Increase Access to COVID-19 Tests 38
Appendix II Summary of Key FDA and HHS Policies That Guided the
Regulation of COVID-19 Tests 40
Appendix III Additional FDA Actions to Support COVID-19 Test Developers 42
Appendix IV Comments from the Department of Health and Human Services 45
Appendix V GAO Contact and Staff Acknowledgments 47
Tables
Table 1: FDA’s Reported Actions to Monitor COVID-19 Tests as of
December 31, 2021 29
Table 2: Key FDA and HHS Policies for the Regulation of COVID-
19 Tests 40
Figures
Figure 1: COVID-19 Test Types 7
Page i GAO-22-104266 FDA Oversight of COVID-19 Tests
Figure 2: Rise in the Cumulative Number of COVID-19 Tests and
Sample Collection Devices with an EUA by FDA, as of
December 2021 12
Figure 3: Number of COVID-19 Tests FDA Authorized and the
Number for Which It Exercised Enforcement Discretion
as of the End of September 2021 22
Abbreviations
CARES Act Coronavirus Aid, Relief, and Economic Security Act
CDC Centers for Disease Control and Prevention
CLIA Clinical Laboratory Improvement Amendments of 1988
EUA emergency use authorization
FDA Food and Drug Administration
HHS Department of Health and Human Services
LDT laboratory developed test
RADx Rapid Acceleration of Diagnostics
This is a work of the U.S. government and is not subject to copyright protection in the
United States. The published product may be reproduced and distributed in its entirety
without further permission from GAO. However, because this work may contain
copyrighted images or other material, permission from the copyright holder may be
necessary if you wish to reproduce this material separately.
Page ii GAO-22-104266 FDA Oversight of COVID-19 Tests
Letter
441 G St. N.W.
Washington, DC 20548
May 12, 2022
Congressional Addressees
The COVID-19 pandemic has had devastating effects on public health
and the economy. As of May 4, 2022, more than 81 million cases of
COVID-19 have been reported in the U.S. since COVID-19 was first
identified in January 2020, and as of the week ending April 30, 2022, over
997,000 deaths associated with COVID-19 have been reported. 1 Testing
for COVID-19 is critical to diagnosing cases and tracking the virus,
informing treatment, and suppressing transmission. Because COVID-19
was caused by a novel virus, no diagnostic test existed at the beginning
of the pandemic. CDC data show that as of May 1, 2022, more than 870
million COVID-19 tests have been performed in the United States. 2
The Food and Drug Administration (FDA), within the Department of
Health and Human Services (HHS), is responsible for ensuring that
medical devices sold in the United States, including diagnostic tests,
provide reasonable assurance of safety and effectiveness. As such, one
1Data on COVID-19 cases in the U.S. are based on aggregate case reporting to CDC and
include probable and confirmed cases as reported by states and jurisdictions. CDC
COVID-19 counts are subject to change due to delays or updates in reported data from
states and jurisdictions. According to CDC, the actual number of COVID-19 cases is
unknown for a variety of reasons, including that people who have been infected may have
not been tested or may have not sought medical care. See CDC, “COVID Data Tracker:
United States COVID-19 Cases, Deaths and Laboratory Testing (NAATs) by State,
Territory, and Jurisdiction,” accessed May 5, 2022, https://covid.cdc.gov/covid-data-
tracker/#cases_totaldeaths.
CDC’s National Center for Health Statistics COVID-19 death counts in the U.S. are based
on provisional counts from death certificate data, which do not distinguish between
laboratory-confirmed and probable COVID-19 deaths. Data are provisional and subject to
updates. In more recent weeks, the data are more likely to be incomplete due to an
average delay of 2 weeks (a range of 1–8 weeks or longer) for death certificate
processing. See CDC, National Center for Health Statistics, “Provisional Death Counts for
Coronavirus Disease 2019 (COVID-19),” accessed May 5, 2022,
https://www.cdc.gov/nchs/nvss/vsrr/covid19/index.htm.
2According to CDC, the testing data represents COVID-19 test results from laboratories in
the United States, including commercial and reference laboratories, public health
laboratories, hospital laboratories, and other testing locations. The data represent
laboratory nucleic acid amplification tests, which include reverse transcriptase-polymerase
chain reaction tests and exclude antibody and antigen tests. See, CDC, “COVID Data
Tracker: United States COVID-19 Cases, Deaths, and Laboratory Testing (NAATs) by
State, Territory, and Jurisdiction,” accessed May 5, 2022, https://covid.cdc.gov/covid-data-
tracker/#cases_totaltests.
Page 1 GAO-22-104266 FDA Oversight of COVID-19 Tests
of FDA’s roles, according to FDA officials, includes determining whether
these tests provide sufficiently accurate and reliable results, and helping
to provide timely access to such tests. Typically, before a medical device
can be marketed in the U.S., it must be approved or cleared by FDA. 3
However, during a public health emergency like the COVID-19 pandemic,
the Secretary of HHS may declare that circumstances justify the
emergency use of unapproved medical products. 4 On February 4, 2020,
the Secretary of HHS declared that circumstances justified FDA’s
issuance of emergency use authorizations (EUA) for tests to detect or
diagnose SARS-CoV-2, the virus that causes COVID-19, until the public
health emergency declaration is terminated.
FDA’s EUA authority allows the agency to authorize tests that it
reasonably believes may be effective to be made available for use. This
authority generally allows for products to be available in a shorter time
frame than typically would be necessary for full approval because it
requires a lower level of evidence than the “effectiveness” standard that is
normally required for FDA product approvals. 5 Additionally, during the
COVID-19 public health emergency, FDA exercised enforcement
discretion for certain COVID-19 tests –that is, FDA did not object to
laboratories’ use of these tests before authorizing them. As part of its
mission to ensure that medical devices are safe and effective, FDA
monitors COVID-19 tests after they reach the market to detect
performance problems or other potential safety issues.
We placed HHS’s leadership and coordination of public health
emergencies on GAO’s High Risk list in January 2022, in part due to
concerns related to HHS’ handling of COVID-19, including testing. HHS’s
response to the COVID-19 pandemic has highlighted longstanding
concerns we raised about the department’s ability to execute its role
3Medical devices must also meet other requirements, such as registration of
manufacturing establishment and device listing with FDA. See 21 C.F.R. pt. 807 (2021).
4See 21 U.S.C. § 360bbb-3(b).
5Medical devices are generally subject to one of two types of FDA premarket review
processes. The premarket approval process, the most stringent type of premarket review,
requires the sponsor to submit evidence providing reasonable assurance that the new
device is safe and effective. The 510(k) process requires the sponsor to demonstrate to
FDA that the new device is substantially equivalent to a device already legally on the
market.
For example, according to FDA, EUA submissions from a commercial manufacturer are
substantially shorter (100 to 200 pages) than what is required when seeking full FDA
approval for a test (about 2,000 pages).
Page 2 GAO-22-104266 FDA Oversight of COVID-19 Tests
leading federal public health and medical preparedness for, and response
to, such public health emergencies.
You asked us to review issues related to FDA’s oversight of COVID-19
tests. In this report, we examine
1. FDA’s actions to help make COVID-19 tests available for use and
stakeholders’ views on those actions;
2. the number of tests FDA authorized and the number for which it
exercised enforcement discretion; and
3. how FDA monitors COVID-19 tests after they are available for use.
In addition, this report is part of our body of COVID-19 work in response
to the Coronavirus Aid, Relief, and Economic Security (CARES) Act. 6 The
CARES Act included a provision for us to report on our ongoing
monitoring and oversight efforts related to the COVID-19 pandemic. 7
To address all three objectives, we reviewed relevant agency
documentation related to EUAs and COVID-19 tests and interviewed
agency officials from FDA’s Center for Devices and Radiological Health to
understand FDA’s policies and processes applicable to COVID-19 tests.
For example, we reviewed multiple iterations of FDA’s Policy for
Coronavirus Disease-2019 Tests During the Public Health Emergency. 8
6We have regularly issued government-wide reports on the federal response to COVID-
19. For the latest report, see GAO, COVID-19: Current and Future Federal Preparedness
Requires Fixes to Improve Health Data and Address Improper Payments, GAO-22-
105397 (Washington, D.C.: Apr. 27, 2022). All of these reports are available on GAO’s
website at https://www.gao.gov/coronavirus.
7Pub. L. No. 116-136, § 19010, 134 Stat. 281, 579-81 (2020).
8Department of Health and Human Services, Food and Drug Administration, Policy for
Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing Under
CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the
Public Health Emergency (Immediately In Effect Guidance for Clinical Laboratories and
Food and Drug Administration Staff) (Silver Spring, Md.: Feb. 29, 2020).
Department of Health and Human Services, Food and Drug Administration, Policy for
Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency
(Immediately In Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and
Food and Drug Administration Staff) (Silver Spring, Md.: Mar. 16, 2020).
Department of Health and Human Services, Food and Drug Administration, Policy for
Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)
(Immediately In Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and
Food and Drug Administration Staff) (Silver Spring, Md.: May 4, 2020).
Page 3 GAO-22-104266 FDA Oversight of COVID-19 Tests
We reviewed publicly available information on FDA’s website about
COVID-19 tests, such as information about tests FDA has authorized and
not authorized and FDA’s responses to frequently asked questions. The
scope of our review did not include an examination of the appropriateness
of FDA’s EUA decisions for COVID-19 tests. Throughout this report, when
we discuss “COVID-19 tests,” we are referring broadly to diagnostic and
antibody tests, unless otherwise specified.
To examine FDA’s actions to help make COVID-19 tests available for
use, stakeholders’ views on those actions, and the extent to which FDA
exercised enforcement discretion for COVID-19 tests, we also reviewed
FDA data and interviewed a selection of associations that represent test
developers. We reviewed FDA data from February 2020 through
December 2021 on the number of EUA requests for tests FDA received,
authorized, and revoked, and on FDA’s EUA review times. In some
cases, we present data in this report as of September 30, 2021 because it
was the end fiscal year 2021 and because it fell in the period prior to
FDA’s issuance of revised guidance in November 2021, which sought to
reduce the number of unauthorized tests that could be used. We
assessed the reliability of these data by asking agency officials about how
FDA stores and maintains the information, and any known reliability
issues. We determined that these data were sufficiently reliable for our
reporting purposes. To examine stakeholders’ views on FDA’s actions,
we conducted interviews with or received written responses from a
nongeneralizable selection of laboratory and device manufacturer
associations. 9 We selected these associations because their members
included COVID-19 test developers. We asked them about their
perspectives on FDA’s policies and processes for reviewing and
authorizing COVID-19 tests.
Department of Health and Human Services, Food and Drug Administration, Policy for
Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)
(Immediately In Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and
Food and Drug Administration Staff) (Silver Spring, Md.: May 11, 2020).
Department of Health and Human Services, Food and Drug Administration, Policy for
Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)
(Guidance for Developers and Food and Drug Administration Staff) (Silver Spring, Md.:
Nov. 15, 2021).
9These interviews included the Association of Public Health Laboratories; AdvaMedDx;
the Medical Device Manufacturers Association; American Clinical Laboratory Association;
the National Independent Laboratory Association; the American Hospital Association; and
the Infectious Diseases Society of America.
Page 4 GAO-22-104266 FDA Oversight of COVID-19 Tests
To keep apprised of FDA’s updates and information FDA shares with test
developers, we listened to FDA’s public Town Hall conference calls for
COVID-19 test developers between February 2021 and January 2022,
which FDA generally held weekly or biweekly. We also reviewed FDA’s
standard operating procedure for COVID-19 test authorization and
publications authored by FDA officials that described FDA’s challenges in
making COVID-19 tests available for use and lessons learned for future
public health emergencies. 10 We also collected information in April 2021
using an email-based questionnaire from the eight states and one territory
that chose to authorize laboratories within their state or territory to
develop COVID-19 tests for emergency use and that perform testing; in
addition, we interviewed officials from one of the states to collect more in-
depth illustrative information about their test review process and
standards. 11 We reviewed the websites of a non-generalizable sample of
25 COVID-19 test developers to determine if their tests appeared to be
available for purchase before FDA had authorized them. In evaluating
FDA’s actions, we considered recommendations in FDA’s 2021 COVID-
19 Pandemic Recovery and Preparedness Plan and FDA’s stated mission
of ensuring access to safe and effective medical devices.
To examine how FDA monitors COVID-19 tests after they are available
for use, we examined FDA documentation and interviewed FDA officials.
We summarized FDA’s use of its enforcement tools for post-market
monitoring of COVID-19 tests. We gathered data on FDA’s use of
enforcement tools from its public website. We interviewed FDA officials
about the process of conducting post-market monitoring for COVID-19
tests, FDA’s use of enforcement tools, and any challenges the agency
has faced in doing so.
We conducted this performance audit from April 2020 to May 2022 in
accordance with generally accepted government auditing standards.
Those standards require that we plan and perform the audit to obtain
sufficient, appropriate evidence to provide a reasonable basis for our
10Jeffrey Shuren and Timothy Stenzel, “COVID-19 Molecular Diagnostic Testing—
Lessons Learned,” New England Journal of Medicine, (Sept. 9, 2020), accessed Sept. 14,
2020, https://www.nejm.org/doi/full/10.1056/NEJMp2023830
Jeffrey Shuren and Timothy Stenzel, “The FDA’s Experience with Covid-19 Antibody
Tests,” New England Journal of Medicine, vol. 384, no. 7 (2021): 592-594.
11The U.S. territory of Puerto Rico did not respond to our email questionnaire, and thus its
responses are not included.
Page 5 GAO-22-104266 FDA Oversight of COVID-19 Tests
findings and conclusions based on our audit objectives. We believe that
the evidence obtained provides a reasonable basis for our findings and
conclusions based on our audit objectives.
We previously reported that CDC developed the first COVID-19
Background diagnostic test in January 2020. 12 However, as we describe in our report,
CDC’s test was flawed, which contributed to the delayed rollout of testing
nationwide. FDA granted an EUA for CDC’s test on February 4, 2020,
and CDC began distributing it to public health laboratories on February 6;
however, many laboratories immediately discovered problems with it. 13
CDC worked to correct the issues with its test and began distributing new
test kits to the laboratories on February 28, 2020. However, no other tests
were available for use outside of CDC until February 29, 2020. 14
COVID-19 Test Types There are three primary types of COVID-19 tests: molecular, antigen, and
antibody. Molecular and antigen tests are diagnostic tests used to detect
a current COVID-19 infection whereas antibody tests are used to identify
if a person had COVID-19 in the past. (See fig. 1.) According to FDA,
diagnostic testing can be performed when a person has signs or
symptoms of infection, when a person is asymptomatic but had recent
exposure, or for screening purposes even if there is no reason to suspect
an individual is infected.
12GAO, COVID-19: Continued Attention Needed to Enhance Federal Preparedness,
Response, Service Delivery, and Program Integrity, GAO-21-551 (Washington, D.C.: July
19, 2021).
13CDC’s first COVID-19 test was called the CDC 2019-Novel Coronavirus (2019-nCoV)
Real-Time RT-PCR Diagnostic Panel. CDC also distributed its test to Department of
Defense laboratories.
We previously reported that a number of public health laboratories reported to CDC that
they could not validate two of the test’s three primer-probe sets, short fragments of genetic
code that can be used to detect a virus’s genetic code.
14According to FDA, the agency did not receive a clinical validation dataset from any test
developer other than CDC until the end of February 2020.
Page 6 GAO-22-104266 FDA Oversight of COVID-19 Tests
Figure 1: COVID-19 Test Types
COVID-19 tests may be developed by a laboratory or by a commercial
manufacturer.
• Laboratory developed test (LDT): a test designed, manufactured,
and used within a single laboratory, for example, a hospital
laboratory. 15
• Commercial test: a test that is developed by a commercial
manufacturer and distributed for use in laboratories or other settings,
such as a physician’s office or an individual’s home. 16
15FDA does not consider tests to be LDTs if they are designed or manufactured
completely, or partly, outside of the laboratory that offers and uses them.
16According to FDA officials, tests developed by large multistate laboratory companies are
considered commercial tests if they are distributed to multiple labs within their network.
Page 7 GAO-22-104266 FDA Oversight of COVID-19 Tests
Commercial COVID-19 tests can be performed in multiple settings and
may or may not require a prescription or order from a health care
provider. Some tests are designed to be performed in a clinical
laboratory, while others are designed to be performed at home or at the
point-of-care, such as a physician’s office, nursing facility, or school, and
generally return a result within 30 minutes or less. 17 Tests that are
designed to be performed in a laboratory require the sample (nasal or
saliva) to be transported from the collection site to the laboratory. Tests
that do not require a prescription are available for purchase over-the-
counter at places such as pharmacies or online. 18
EUAs for COVID-19 Tests Medical products are eligible for EUA if they meet the following broad
statutory criteria, which are described in FDA guidance. 19
• They may be effective to prevent, diagnose, or treat a serious or life-
threatening disease or condition,
• The known and potential benefits of the product outweigh the known
and potential risks, and
• No adequate, approved and available alternatives to the product exist.
17We define a clinical laboratory as a facility that examines samples derived from humans
for the purpose of disease diagnosis, prevention, and treatment, or health assessment of
individuals. See 42 U.S.C. § 263a(a). Under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), clinical labs that perform tests on human specimens to
diagnose, prevent, or treat disease must meet certain requirements. See Pub. L. No. 100-
578, § 2, 102 Stat. 2903 (codified as amended at 42 U.S.C. § 263a). The Centers for
Medicare & Medicaid Services has issued regulations to implement CLIA and is
responsible for overseeing and certifying compliance with these regulations.
Point-of-care testing is testing that is performed at a patient care setting, such as a
doctor’s office or school, and must be performed in a facility operating under a CLIA
Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
18FDA distinguishes between direct-to-consumer tests, which are non-prescription tests
where the sample collection device is purchased over the counter and the sample is
mailed to a laboratory to perform the test, and over-the-counter tests, which are performed
entirely at home.
19Department of Health and Human Services, Food and Drug Administration, Emergency
Use Authorization of Medical Products and Related Authorities (Guidance for Industry and
Stakeholders) (Silver Spring, Md.: Jan. 2017).
The criteria for an EUA listed in these bullets are only a partial list of the criteria and
requirements for authorization under section 564 of the Food, Drug, and Cosmetic Act
(see 21 USC 360bbb-3(c)).
Page 8 GAO-22-104266 FDA Oversight of COVID-19 Tests
An EUA continues in effect unless and until it is revoked or the
declaration allowing FDA to issue EUAs terminates.
Under FDA’s process, a test developer submits an EUA request to FDA
that includes data on the test’s accuracy and reliability. FDA reviews the
EUA request and evaluates, among other things, whether the developer
has provided sufficient data to demonstrate that the test meets the
agency’s expectations for reliability and accuracy and whether the
scientific evidence provided supports the test’s intended use. According
to FDA officials, the agency quickly became inundated with EUA requests
from COVID-19 test developers, receiving over 100 requests by the end
of March 2020 and more than 3,000 by the end of fiscal year 2021.
FDA recommends that EUA requests for COVID-19 tests include
information about the test, its intended use and testing capacity and data
showing the results of studies developers conducted to validate the test’s
performance characteristics. 20 FDA may work with the test developer to
correct any problems identified during the review of the request. FDA may
grant, deny, or decline the EUA request. 21 If FDA grants the EUA request,
the test is then authorized and may be used or distributed, as set forth in
the terms of the EUA. If FDA denies or declines the EUA request, then it
may not be used or distributed.
Receipt of an EUA carries certain benefits for COVID-19 test developers.
For example, medical products, including tests, with an EUA are qualified
for coverage under the Public Readiness and Emergency Preparedness
Act, which may provide certain liability protection to individuals and
entities, such as test manufacturers, against claims of loss caused by or
20Validation studies are designed to assess a test’s sensitivity and specificity, among
other things. Sensitivity is the measure of how often the test correctly returns a positive
result for someone who has a SARS-CoV-2 infection, and specificity is the measure of
how often the test correctly returns a negative result for someone who does not have a
SARS-CoV-2 infection. For example, FDA recommended a minimum sensitivity of 95
percent and specificity of 98 percent for laboratory based molecular diagnostic tests.
21According to FDA officials, the agency may decline to issue the EUA if the request does
not include all the necessary data and information for a substantive review. FDA may deny
the request if the totality of evidence in the request does not meet statutory criteria. FDA
officials told us they give test developers 48 hours to address any deficiencies FDA finds
in the EUA submission before declining to issue the EUA. FDA may also decline to review
the request if the test is not a priority that will address the public health needs at the
current stage of the public health emergency.
Page 9 GAO-22-104266 FDA Oversight of COVID-19 Tests
relating to their manufacture, distribution, administration, or use. 22 In
addition, section 6001 of the Families First Coronavirus Response Act, as
amended by section 3201 of the CARES Act, requires most private health
insurance plans to cover the cost of COVID-19 testing, administration of
the test, and related items and services, as defined by the acts. 23 This
includes insurance coverage for COVID-19 tests that have been
approved, cleared, or authorized by FDA, or where the developer has
requested or intends to request an EUA, unless and until that EUA has
been denied or the developer does not submit a request within a
reasonable time frame.
FDA took several actions aimed at rapidly increasing the availability of
FDA Took Various tests in the United States. These actions included granting EUAs for
Actions to Help COVID-19 tests; issuing policies that enabled some tests to be used
without first obtaining an EUA; and increasing its resources dedicated to
Increase the COVID-19 tests and prioritizing EUA requests to manage the large
Availability of COVID- number of EUA submissions.
19 Tests
FDA Granted EUAs for The primary way FDA helped to increase the availability of COVID-19
COVID-19 Tests tests was by authorizing tests for emergency use—that is, granting them
EUAs. Following the authorization of CDC’s COVID-19 test on February
4, 2020, FDA granted the second EUA for a COVID-19 test to the New
York State Department of Health on February 29, 2020, and had
authorized 23 tests by March 31, 2020. By December 31, 2021, FDA had
granted EUAs for 420 COVID-19 tests and sample collection devices—
290 molecular tests and sample collection devices, 43 antigen tests, and
87 antibody and other immune response tests. 24 (See fig. 2.) These
included
22See 42 U.S.C. § 247d-6d. COVID-19 tests that are approved or cleared under FDA’s
traditional review process also qualify for coverage under the Public Readiness and
Emergency Preparedness Act.
23Families First Coronavirus Response Act, Pub. L. No. 116-127, § 6001, 134 Stat. 178,
201-02 (2020); CARES Act, Pub. L. No. 116-136, § 3201, 134 Stat. 281, 366-67 (2020).
24A sample collection device can be used for collecting a clinical sample (e.g., nasal or
saliva) and sending the sample to a laboratory for testing with a molecular diagnostic test,
and, according to FDA officials, may be authorized individually or as part of a home
collection kit.
Page 10 GAO-22-104266 FDA Oversight of COVID-19 Tests
• Thirteen over-the-counter antigen tests that could be performed at
home and three over-the-counter molecular at-home tests, and
• 67 molecular tests and one antibody test that could be used with
home-collected samples.
With a home collection test, the sample is collected at home but analyzed
in a laboratory. With an at-home test, the consumer collects the sample
and conducts the test at home.
Page 11 GAO-22-104266 FDA Oversight of COVID-19 Tests
Figure 2: Rise in the Cumulative Number of COVID-19 Tests and Sample Collection Devices with an EUA by FDA, as of
December 2021
Note: According to FDA officials, monthly counts reflect the cumulative total of emergency use
authorizations (EUA) granted minus any EUA revocations.
Page 12 GAO-22-104266 FDA Oversight of COVID-19 Tests
FDA Policy Enabled Some Shortly after the Secretary’s February 4, 2020, declaration that
Tests to Be Used Before circumstances justified FDA’s issuance of EUAs for COVID-19 tests, FDA
issued four policies, each with the intention of expediting the availability of
Authorizing Them for
tests. Specifically, FDA exercised enforcement discretion to not object to
Emergency Use and FDA the use of certain kinds of COVID-19 before they received an EUA. 25
Took Actions to Support These policies only pertained to tests performed by certain types of
Test Developers laboratories, and did not apply to tests that could be performed at home
or on samples collected at home.
• First, on February 29, 2020, FDA issued an enforcement discretion
policy that enabled certain types of laboratories to begin using
diagnostic tests they developed prior to obtaining an EUA. 26 This
policy applied only to laboratories certified under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA) that met the
regulatory requirements to perform high complexity testing and that
were developing diagnostic tests for use in their own laboratory—
LDTs. 27 These laboratories could begin using their diagnostic test
after they validated them and notified FDA that they intended to begin
using their tests while they were preparing or awaiting FDA’s review of
their EUA requests. 28 Under this policy, once a laboratory notified
FDA that it had validated its test, it was to submit its EUA request to
25We use the term enforcement discretion to refer to FDA’s policy to not object to the use
of COVID-19 tests that did not comply with applicable statutory or regulatory
requirements, including the requirement to obtain pre-market approval or emergency use
authorization prior to use.
26Food and Drug Administration, Policy for Diagnostics Testing in Laboratories Certified to
Perform High Complexity Testing Under CLIA prior to Emergency Use Authorization for
Coronavirus Disease-2019 during the Public Health Emergency, Feb. 29, 2020. This
document states, “The guidance issued today describes a policy enabling laboratories to
immediately use tests they developed and validated in order to achieve more rapid testing
capacity in the U.S.”
27Laboratories obtain CLIA certificates based on the kinds of diagnostic tests they
conduct. FDA assigns the tests to one of three CLIA complexity categories—waived,
moderate complexity, or high complexity—that determine which laboratories can use
particular tests once they are on the market. Laboratories conducting moderate- to high-
complexity tests undergo biennial inspections—also referred to as surveys—that assess
laboratory compliance with personnel and testing standards. According to the Centers for
Medicare & Medicaid Services, as of August 2021, there were approximately 34,000
CLIA-certified laboratories that may be able to perform high complexity testing if they had
appropriately qualified personnel as outlined in the regulations.
28Validation studies are designed to assess a test’s performance characteristics.
Page 13 GAO-22-104266 FDA Oversight of COVID-19 Tests
FDA within 15 business days. Once notified, FDA did not object to the
laboratory’s use of the test and placed the test on a notification list. 29
• Second, on March 16, 2020, FDA announced a similar policy for
diagnostic tests developed by commercial manufacturers, in which
FDA indicated it would not object to commercial test manufacturers’
distribution of the test, provided the manufacturers first validated the
tests, notified FDA the tests had been validated, and submitted an
EUA request to FDA within 15 business days after validating the
test. 30 In doing so, FDA cited increasing numbers of COVID-19 cases
throughout the country and the urgent need to expand the nation’s
capacity for COVID-19 testing during the public health emergency.
FDA later stated that use of these tests was limited to laboratories
certified under CLIA to perform high-complexity testing. 31 After
notification, FDA placed the test on a “notification list.”
• Third, on March 16, 2020, FDA announced it did not intend to object
to the distribution or use of antibody tests for use by certain
laboratories without an EUA if the developer had validated the test
and notified FDA. 32 Unlike for diagnostic tests falling within the
29FDA maintained four separate notification lists on its website: one for diagnostic tests
developed by laboratories, one for antibody tests developed by laboratories, one for
diagnostic tests developed by commercial manufacturers, and one for antibody tests
developed by commercial manufacturers. Food and Drug Administration, “Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2,” accessed Oct.
22, 2021, https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-
devices/notifications-and-emergency-use-authorizations-faqs-testing-sars-cov-2.
30Food and Drug Administration, Policy for Diagnostic Tests for Coronavirus Disease-
2019 Tests During the Public Health Emergency, Mar. 16, 2020.
31Food and Drug Administration, Policy for Coronavirus Disease-2019 Tests During the
Public Health Emergency (Revised), May 4, 2020. FDA stated that, unless and until an
EUA is issued that authorizes additional testing environments for a specific test, use of
that test is limited to laboratories that are certified under CLIA and meet the requirements
to perform tests of high-complexity, and at the point-of-care when covered by such a
laboratory’s CLIA certificate.
32FDA also recommended developers include certain information in the test result reports,
including a statement that the test had not been reviewed by FDA and that results from
antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2
infection.
FDA later stated in its May 4, 2020, policy that use of antibody tests prior to or without an
EUA was limited to laboratories certified under CLIA that met the requirements to perform
tests of high-complexity, and at the point-of-care when covered by a laboratory’s CLIA
certificate. Food and Drug Administration, Policy for Coronavirus Disease-2019 Tests
During the Public Health Emergency (Revised), May 4, 2020.
Page 14 GAO-22-104266 FDA Oversight of COVID-19 Tests
enforcement discretion policies, FDA did not at first expect antibody
test developers to submit an EUA request to FDA. FDA stated that it
issued this policy based, in part, on the fact that antibody tests were
not intended to be used for diagnostic purposes and because FDA
believed access to antibody tests was important to help the scientific
community understand the scope of the COVID-19 outbreak.
However, according to FDA officials, many poorly performing or
fraudulent antibody tests soon began to flood the market. In response,
FDA revised its policy on May 4, 2020, stating that the agency
expected commercial manufacturers of antibody tests to request
EUAs for these tests. 33 In April 2020, FDA partnered with the National
Cancer Institute, the National Institute of Allergy and Infectious
Diseases, CDC, and the Biomedical Advanced Research and
Development Authority to evaluate the performance of antibody tests
to help inform FDA’s authorization decisions. Ultimately, FDA
removed more than 260 antibody tests developed by commercial
manufacturers from FDA’s notification list due to significant problems
with the test that were not addressed in a timely manner or because
the manufacturer did not submit an EUA request within10 business
days, and expected developers to remove them from the market. 34
FDA officials stated in a New England Journal of Medicine article that
the March 16, 2020, antibody test policy was “flawed.” 35
• Fourth, FDA’s policies enabled states and territories to authorize
laboratories within their state or territory to develop their own COVID-
19 tests and perform testing without an EUA. On March 16, 2020,
FDA announced it would not object to the development and use of
certain laboratory tests without EUAs where states and territories
reviewed and authorized laboratories within their own state or territory
33Specifically, FDA modified its COVID-19 test guidance to reflect that commercial
manufacturers of antibody tests were expected to submit an EUA request to FDA within
10 business days after notifying FDA that the test had been validated or the date of
publication of the guidance (May 4, 2020), whichever was later. Laboratories were
encouraged, but not required, to submit EUA requests for antibody tests. Food and Drug
Administration, Policy for Coronavirus Disease-2019 Tests During the Public Health
Emergency (Revised), May 4, 2020.
34As of July 30, 2021, FDA had removed 268 commercially developed antibody tests from
its notification list.
35Shuren and Stenzel, “The FDA’s Experience with Covid-19 Antibody Tests.”
Page 15 GAO-22-104266 FDA Oversight of COVID-19 Tests
to perform COVID-19 testing. 36 As stated in FDA’s policy, the agency
intended this policy to expedite COVID-19 testing. Eight states and
one U.S. territory subsequently notified FDA of their intention to do
this. 37 We contacted these states and the U.S. territory and found that
six states had authorized laboratories in their state to develop their
own COVID-19 tests, and all six states used FDA’s guidance when
developing their review processes. 38
See appendix I for information about actions FDA took to help increase
the availability of tests. See appendix II for a summary of key FDA and
HHS policies for the regulation of COVID-19 tests.
Representatives from associations we interviewed whose members
include COVID-19 test developers provided various views on FDA’s
actions and policies to help increase the availability of tests throughout
the pandemic. Specifically, these stakeholders told us that FDA’s use of
enforcement discretion for COVID-19 tests was instrumental in rapidly
increasing testing capacity at the beginning of the pandemic, but also
expressed some concerns with FDA’s policies. For example,
representatives from two associations told us they believed FDA’s use of
enforcement discretion for certain tests without an EUA was helpful
because they allowed tests to become available quickly when the
demand for tests was great. However, two stakeholders noted that FDA’s
EUA process at the beginning of the pandemic may have stymied the
nation’s testing response when the U.S. had limited testing capacity and
when testing was crucial to stemming the spread of the virus. A
representative from one of these associations noted that they would have
liked FDA to not object to the use of LDTs without an EUA earlier in the
pandemic. (For more information about the EUA requirements for COVID-
19 LDTs, see text box.)
36Food and Drug Administration, Policy for Diagnostic Tests for Coronavirus Disease-
2019 Tests During the Public Health Emergency, March 16, 2020. Under this policy, the
laboratories would not submit an EUA request to FDA for their tests.
37Those states and U.S. territory were Colorado, Connecticut, Maryland, Mississippi,
Nevada, New Jersey, New York, Washington, and Puerto Rico. Puerto Rico did not
respond to our request for additional information.
38As of April 2021, these six states authorized 91 laboratories that developed 121
molecular tests, and 19 laboratories that developed 23 antibody tests.
Page 16 GAO-22-104266 FDA Oversight of COVID-19 Tests
Changes to the Emergency Use Authorization Policies for COVID-19 Laboratory Developed Tests
The Food and Drug Administration’s (FDA) policies regarding the regulation of laboratory developed tests (LDT), including
COVID-19 LDTs, changed over the course of the pandemic. While FDA considers LDTs to be a type of diagnostic device, the
agency has generally exercised enforcement discretion for most LDTs and has not asserted its jurisdiction to regulate them
because they traditionally were relatively simple tests available on a limited basis. FDA has reconsidered this policy, as some
LDTs have become more complex and available nationwide. For example, at the beginning of the COVID-19 pandemic,
rather than exercise enforcement discretion for COVID-19 LDTs, FDA required these tests to obtain FDA authorization. FDA
officials told us that FDA expected laboratories developing COVID-19 LDTs to comply with the emergency use authorization
(EUA) requirements because of FDA’s concern that poorly performing tests can undermine the nation’s response to a public
health emergency. Officials also told us that FDA expected LDTs used in six previous public health emergencies, including
the H1N1 and Zika emergencies, to have EUAs.
On August 19, 2020, however, the Department of Health and Human Services (HHS) announced that FDA would no longer
require premarket EUA reviews for LDTs unless FDA went through the notice and comment rulemaking process, although
laboratories could continue to submit EUA requests for LDTs voluntarily. FDA subsequently announced its intention to
decline to review EUA requests for COVID-19 LDTs in October 2020. Two laboratory associations we spoke with had
unfavorable views of FDA’s decision to decline to review LDTs, noting that it created uncertainty and confusion among
laboratories, particularly around insurance coverage and liability protection under the Public Readiness and Emergency
Preparedness Act for LDTs without an EUA.
On November 15, 2021, HHS announced that it was withdrawing its LDT policy, thereby reinstating FDA’s approach to
regulating LDTs. On the same day, FDA issued a policy under which it expected COVID-19 tests, including LDTs, to have an
EUA prior to use.
Source: GAO summary of FDA and HHS information and interviews with laboratory associations | GAO-22-104266
Representatives from three associations told us that many laboratories
found it difficult to apply for an EUA for their tests because they were
unfamiliar with FDA’s EUA requirements and did not have the resources
or internal expertise needed to navigate FDA’s EUA process. FDA
acknowledged that some laboratories were unfamiliar with the EUA
process, and that this created misunderstandings and confusion.
Representatives from two associations noted that the EUA requirements
were not very transparent early in the pandemic and one noted they
would have liked to see more early education from FDA on the EUA
process for laboratories. Representatives from another association told us
they often felt there was a disconnect when FDA talked to laboratory test
developers because FDA was most accustomed to working with other
types of manufacturers. They said it would have been useful to have
direct engagement by FDA with clinical laboratories and for FDA to have
dedicated staff to work with the clinical laboratory sector. FDA officials
told us that communication with laboratories is “ripe for improvement” and
the agency intends to develop a plan to improve communication with
laboratories to better prepare for a future public health emergency. We
recommended in July 2021 that CDC work with appropriate stakeholders
Page 17 GAO-22-104266 FDA Oversight of COVID-19 Tests
to develop a plan to enhance surge capacity for laboratory testing. 39 CDC
agreed with our recommendation and noted in its response that FDA also
plays a critical role in increasing surge capacity by authorizing tests for
emergency use. In May 2022, CDC developed a laboratory testing surge
capacity plan in consultation with external partners and FDA joined a
memorandum of understanding with CDC and multiple laboratory
associations. We are reviewing the plan to determine if it meets our
recommendation. These are positive first steps and we will continue to
monitor CDC’s progress on this effort.
Our review of agency documentation shows that FDA took several
actions to improve communication with test developers and support them
during the test development and EUA process. For example, FDA
developed EUA templates to help guide test developers as they prepared
their EUA requests, engaged with test developers through the pre-EUA
process, held regular public conference calls, and supplied panels of viral
material to test developers. FDA stated that the agency had interacted
with over 1,000 COVID-19 test developers. According to the associations
we spoke with, test developers generally found these actions to be
helpful. See appendix III for additional information and stakeholders’
views about FDA’s actions to support COVID-19 test developers.
To Manage the Large FDA took various actions to address the large volume of EUA requests
Number of EUA Requests, the agency received for COVID-19 tests. According to FDA officials, the
agency received a very high number of EUA requests for tests—nearly
FDA Increased Resources
3,400—from February 2020 through December 2021, which represents
and Prioritized Among an average of about 150 per month. During this time, FDA data show that
Requests the agency’s average time to review EUA requests and make
authorization decisions increased from 3 days, in March 2020, to 65 days
as of December 2021, for all types of tests. 40 FDA officials told us that as
the volume of EUA requests increased, so did FDA’s average review
times. Representatives from four associations we talked to also told us
that FDA’s time to review EUA requests increased significantly over time,
which, according to one association, caused frustration among some
members.
39GAO, COVID-19: Continued Attention Needed to Enhance Federal Preparedness,
Response, Service Delivery, and Program Integrity, GAO-21-551 (Washington, D.C.: July
19, 2021).
40According to data that we received from FDA, average review times varied by test
type—about 56 days for antigen tests and about 101 days for antibody tests as of
December 2021.
Page 18 GAO-22-104266 FDA Oversight of COVID-19 Tests
FDA’s efforts to address the large number of EUA requests for tests
included increasing the number of EUA reviewers and prioritizing which
tests to review. FDA officials told us that, as of October 2021, the agency
was making an average of 23 EUA decisions for COVID-19 tests per
week.
FDA temporarily increased the number of EUA reviewers. According
to FDA officials, the agency increased the number of staff working on
EUAs for COVID-19 tests from 60 in March 2020 to 180 by March 2021 to
handle the high volume of submissions. Officials told us the agency
assigned nearly all staff from the Division of Microbiology Devices to
respond to COVID-19 in March 2020, leaving only two staff from that
division to work on non-COVID devices at that time. FDA also assigned
staff from other divisions to work on the COVID testing response. As a
result of these staff reassignments, according to FDA officials, non-
COVID diagnostic devices experienced longer-than-usual review times
and delays in initiating reviews. FDA officials explained that the agency
began shifting staff back to non-COVID work in May 2021.
FDA also hired new reviewers and leveraged contractors to support the
increased workload due to COVID-19 EUA requests. According to FDA
officials, the Division of Microbiology Devices increased in size by 28
reviewers from the beginning of 2020 to November, 2021. FDA also hired
term and temporary staff, including contractors, to provide technical
expertise to support the review of EUA requests with funds provided
under the American Rescue Plan Act of 2021 and the Paycheck
Protection Program and Health Care Enhancement Act, according to FDA
officials. FDA officials told us the agency intended to hire additional
review staff and leverage contractor support where appropriate. FDA
noted in a January 2021 report that some of the potential options to
improve the agency’s pandemic preparedness could require additional
staff capacity or funding. 41
FDA prioritized EUA requests for certain tests and declined to
review requests for nonpriority tests. FDA shifted its priorities to meet
the changing circumstances of the public health emergency. In October
2020, FDA announced on its website and in virtual Town Hall meetings
that it would begin prioritizing its review of EUA requests for certain types
41Food and Drug Administration, FDA COVID-19 Pandemic Recovery and Preparedness
Plan (PREPP) Initiative: Summary Report (Silver Spring, Md.: Jan. 13, 2021).
Page 19 GAO-22-104266 FDA Oversight of COVID-19 Tests
of COVID-19 tests and declining to review EUA requests for LDTs. 42
Specifically, FDA stated it would prioritize its review of EUA requests for
tests where authorization would increase testing accessibility (e.g., point
of care tests, home collection, or at-home tests) or would significantly
increase testing capacity, such as tests that reduced reliance on supplies
or high-throughput tests. FDA stated on its website that, in light of the
August 2020 HHS announcement that FDA will not require premarket
review of LDTs, and to make “best use of [their] resources for the greatest
public health benefit,” FDA began declining to review EUA requests for
LDTs. FDA officials told us that as of September 30, 2021, they had
declined to review 558 EUA requests for COVID-19 tests, including 230
LDTs. In its revised guidance, issued on November 15, 2021, FDA
described in detail how it would determine a test’s potential to significantly
increase testing capacity and accessibility. 43
FDA Authorized 412
Tests and Exercised
Enforcement
Discretion for 370
Unauthorized Tests
42Food and Drug Administration, “COVID-19 Test Development and Review: FAQs for
Testing on SARS-CoV-2,” accessed Jan. 15, 2021,
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19.
FDA also discussed its priorities for reviewing EUA requests at the public Town Hall
conference calls for COVID-19 test developers.
43Food and Drug Administration, Policy for Coronavirus Disease-2019 Tests During the
Public Health Emergency (Revised), Nov. 15, 2021. For example, the guidance stated
that, for laboratory-based molecular diagnostic tests, FDA intended to focus on tests that
were highly sensitive; high volume; intended for pooled testing, home sample collection, or
had the ability to detect multiple viruses at once; and that were developed by experienced
developers with the ability to scale up manufacturing capacity shortly after authorizations.
The guidance stated the FDA’s view that authorization of tests with manufacturing
capacities lower than 500,000 tests per week would not sufficiently scale U.S. testing
capacity.
Page 20 GAO-22-104266 FDA Oversight of COVID-19 Tests
FDA Granted EUAs for Our analysis of FDA data shows that as of September 30, 2021, FDA had
412 Tests and Did Not granted EUAs for 412 COVID-19 tests. In addition, there were 370 tests—
285 LDTs and 85 tests developed by commercial manufacturers—for
Object to the Use of 370
which FDA had received EUA requests but had not yet reviewed to make
Tests It Had Not an EUA determination as of September 30, 2021. FDA exercised its
Authorized, as of the End enforcement discretion to not object to the tests’ use by certain types of
of September 2021 laboratories, or their distribution by test developers. FDA placed these
unauthorized tests on notification lists and stated on its website that tests
on a notification list that are offered prior to or without an EUA have not
been reviewed or authorized by FDA. 44 FDA did not know whether these
tests were actually manufactured, distributed, or used, because according
to FDA officials, the agency does not track the number of distributed
COVID-19 tests or the number in use. However, we found through a
review of a non-generalizable sample of 25 tests on the notification lists
that some of the tests on the notification lists appeared to be available for
purchase by laboratories. 45 See Figure 3 for the number of COVID-19
tests that FDA authorized and the number for which it exercised
enforcement discretion as of September 30, 2021.
44Food and Drug Administration, “FAQs on Testing for SARS-CoV-2,” accessed February
14, 2022, https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-
devices/faqs-testing-sars-cov-2.
45We reviewed the websites of a non-generalizable sample of 25 of the 47 commercial
diagnostic tests on a notification list, as of October 21, 2021. While it was not always clear
from the websites whether the tests were available for purchase, our review found that at
least 5 appeared to be available for purchase. For example, one website we considered to
be unclear stated that test’s availability would be updated once FDA authorized it, but also
provided ordering information.
Page 21 GAO-22-104266 FDA Oversight of COVID-19 Tests
Figure 3: Number of COVID-19 Tests FDA Authorized and the Number for Which It
Exercised Enforcement Discretion as of the End of September 2021
Note: COVID-19 tests that were unauthorized as of September 30, 2021, were those for which FDA
exercised enforcement discretion—that is, FDA did not object to their use, offering, or distribution, but
had not yet authorized for emergency use. Of the 370 unauthorized tests, 285 were developed by
laboratories and 85 were developed by commercial manufacturers. FDA officials did not know
whether these tests were manufactured, used, or distributed. FDA’s policy limited use of these tests
to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 that met the
requirements to perform tests of high complexity.
FDA officials told us that by the spring of 2020, they began having
concerns about the potential risks these unauthorized tests presented.
While FDA checks for obvious problems with the data included in EUA
requests, officials said this cursory check did not provide assurance that
these tests were sufficiently accurate and reliable. According to FDA
officials, it was not until FDA reviewed an EUA request that certain issues
that could signal a problem with a test could be found. For example, FDA
ultimately denied the EUA requests for several LDTs that had previously
been available for use due to performance problems or poor validation. 46
46In 2020, FDA conducted an analysis of the first 125 EUA requests that it received from
laboratories. Of these 125 requests the agency identified 82 EUA requests with design
and validation problems. FDA worked with the laboratories to correct the issues but the
agency ultimately denied authorization to several of these EUA requests.
Page 22 GAO-22-104266 FDA Oversight of COVID-19 Tests
This concern is understandable given that many tests on the notification
lists remained available for use for many months before FDA conducted
its review of the EUA requests. For example, in June 2021, FDA officials
told us the longest a commercial antibody test was on a notification list
was 359 days before the agency declined to authorize it. We also found
that 65 percent of the commercial diagnostic tests that were on a
notification list in November 2021 had been on the list for at least a year.
On November 15, 2021, FDA issued a revised COVID-19 test policy
intended to address the potential risk of the large number of unauthorized
tests on the notification lists. The policy sought to phase out the agency’s
use of enforcement discretion for tests and reduce the number of tests on
the notification lists. 47 FDA stated that the agency no longer intended to
add tests to the notification lists and that test developers who had
submitted their EUA request prior to February 1, 2021, should inform FDA
within 45 calendar days from the issuance date of the policy if they still
wanted FDA to review their EUA request. According to the policy, FDA
intended to decline to review any tests for which the agency did not
receive confirmation from the developer, and expected the developer to
cease making their test available for use. FDA officials told us that the
agency’s goal was to reduce the number of tests remaining on the
notification lists and eventually phase out the lists altogether. FDA
officials told us that they generally intended to review the remaining tests
on the notification lists as time and resources allowed, and as of April 11,
2022, 68 tests remained on the notification lists. 48
According to FDA officials, an example of an issue that may not be found until FDA did a
full review of an EUA request for COVID-19 tests included test developers using contrived
samples instead of live viral samples to validate their test.
47Food and Drug Administration, Policy for Coronavirus Disease-2019 Tests During the
Public Health Emergency (Revised), Nov. 15, 2021.
48As of April 8, 2022, 12 diagnostic tests and five antibody tests developed by commercial
manufacturers remained on the notification list, as well as 26 laboratory developed
diagnostic tests and 25 laboratory developed antibody tests.
Page 23 GAO-22-104266 FDA Oversight of COVID-19 Tests
FDA Does Not Have a When FDA exercised enforcement discretion for tests it had not
Policy for the Use of authorized for emergency use, the agency did not indicate when and
under what conditions it would end the use of enforcement discretion and
Enforcement Discretion
begin objecting to the use of unauthorized tests. FDA stated in its policy
Regarding Unauthorized that its intention for exercising enforcement discretion early in the
Tests In Future Public pandemic was to rapidly increase test availability due to urgent public
Health Emergencies health concerns at that time. 49 However, agency officials also told us that
by the fall of 2020, when nearly 300 tests had been granted EUAs, they
believed the risks of having unauthorized tests available for use began to
outweigh the benefits.
FDA officials told us that they have made numerous efforts to prepare for
the next pandemic and that they hoped the agency would never again be
in a position where it would need to consider the use of unauthorized
tests in response to a public health emergency. 50 However, the COVID-19
pandemic demonstrated that an emerging infectious disease can exceed
the nation’s existing testing capacity and it is possible that FDA could
once again find itself in a position where it would consider it necessary to
permit the use of unauthorized tests to rapidly expand testing capacity. If
FDA were to again exercise such discretion without a policy for when it
would end the discretion, hundreds of unauthorized tests—whose
accuracy and reliability would be uncertain—could once again be
available for use for an extended period of time.
49Food and Drug Administration, Policy for Diagnostics Testing in Laboratories Certified to
Perform High Complexity Testing Under CLIA prior to Emergency Use Authorization for
Coronavirus Disease-2019 during the Public Health Emergency (Immediately In Effect
Guidance for Clinical Laboratories and Food and Drug Administration Staff), Feb. 29,
2020.
50FDA officials identified lessons learned from the COVID-19 emergency they said should
inform the U.S. government’s response to future outbreaks, such as authorizing a small
number of well-developed and validated tests and using contract manufacturers at the
outset to greatly increase test availability. See Shuren and Stenzel, “COVID-19 Molecular
Diagnostic Testing—Lessons Learned.”
FDA officials told us they agreed with a 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 public health emergency to speed the availability of future
diagnostic devices. See Booz Allen Hamilton, Deliverable 15: Emergency Use
Authorization Assessment – Final Report, (McLean, Va.: 2021).
Page 24 GAO-22-104266 FDA Oversight of COVID-19 Tests
FDA officials told us they had not developed a policy or criteria for the use
of enforcement discretion regarding unauthorized tests in future public
health emergencies. Developing such a policy could potentially minimize
the length of time that unauthorized tests would be available for use and
would be consistent with FDA’s 2021 COVID Pandemic Recovery and
Preparedness Plan Initiative Report, which recommends that the agency
expand its scenario planning to inform strategic decisions and actions for
the agency’s ongoing response to COVID-19 and for future
emergencies. 51 Additionally, having a policy that outlines the
circumstances under which FDA would and would not object to the use of
unauthorized tests would be consistent with FDA’s mission to protect the
public health by ensuring that medical devices are safe and effective,
which involves determining if tests are sufficiently accurate and reliable.
Unless FDA develops a policy for the use of enforcement discretion in
future public health emergencies— including the conditions under which
FDA would begin and end such discretion—FDA could face the risk that
unauthorized tests with uncertain accuracy and reliability could be used
for an extended period of time, even when a sufficient number of tests are
available. This could hamper an effective response and recovery during a
crisis.
FDA relies on mandatory and voluntary reporting by test developers and
FDA Monitors others to conduct post-market monitoring of COVID-19 tests. FDA has
Reports of taken a variety of actions throughout the public health emergency to
address problems found through this monitoring process, including test
Performance developers’ violations of the Food, Drug, and Cosmetic Act. According to
Problems with FDA officials, FDA shifted its resources to address the resource
challenges it faced in conducting post-market monitoring for COVID-19
COVID-19 Tests and tests.
Takes Action to
Address Them
51Food and Drug Administration, FDA COVID-19 Pandemic Recovery and Preparedness
Plan (PREPP) Initiative: Summary Report, Jan. 13, 2021.
Page 25 GAO-22-104266 FDA Oversight of COVID-19 Tests
FDA Relies on Test Device manufacturers and user facilities, such as nursing homes and
Developers, Health Care hospitals, that use COVID-19 tests are required to report certain types of
reportable events to FDA. Reportable events include death and serious
Providers, and Consumers
injury events that a device has caused or may have contributed to, as well
to Report COVID-19 Test as a device malfunction that would be likely to cause or contribute to a
Performance Problems death or serious injury if it were to recur. 52 According to FDA, in the case
of COVID-19 tests, reportable events include instances of false positive or
false negative test results. FDA has publicly stated that false test results
can contribute to the spread of COVID-19, and that, in a public health
emergency, getting an accurate test result is important not only for the
individual patient, but for the public at large.
To conduct post-market monitoring of COVID-19 tests, FDA relies on
mandatory self-reporting by test developers and user facilities, and
voluntary reporting by health care providers and consumers. FDA has two
primary systems for receiving adverse event reports, the Electronic
Medical Device Reporting system and MedWatch. Device manufacturers
are required to submit reports electronically via the Electronic Medical
Device Reporting system, and patients and health care providers can
submit complaints about COVID-19 tests online via MedWatch. FDA
officials told us the agency may also receive emails about false positive or
false negative test results or other performance concerns from
laboratories and others using diagnostic COVID-19 tests. FDA officials
told us the agency internally tracks adverse event reports the same way
for each of the three reporting routes.
FDA officials told us that the volume of adverse event reports has been
high for COVID-19 tests and that the agency does not investigate every
individual report it receives. Specifically, the agency received 18,432
adverse event reports for COVID-19 tests as of December 31, 2021.
According to FDA officials, rather than investigate every adverse event
report, the agency monitors adverse event reports it receives for signals,
such as a high volume of reports on the same test, potential severity of
adverse events, or a trend that may indicate a performance problem with
a test. FDA officials told us FDA’s post-market monitoring team also
coordinates with FDA’s pre-market review team, which would have
initially reviewed the EUA request for a given test to determine whether a
52See 21 C.F.R. Pt. 803 (2021), Medical Device Reporting; 21 C.F.R. § 803.3 (2021)
(definition of reportable event).
Page 26 GAO-22-104266 FDA Oversight of COVID-19 Tests
signal is particularly concerning, and when and if further investigation may
be needed.
According to FDA officials, if FDA identifies a signal from reports of
adverse events, FDA will initiate an investigation by reaching out to the
test developer to inquire about its awareness of the potential issue. FDA
may also request additional information or data from a test developer
when it believes that the emergence of a COVID-19 viral variant may
affect a test’s performance (see text box, below).
Monitoring Test Performance with Emerging COVID-19 Viral Variants
Mutations in the genetic makeup of the SARS-CoV-2 virus—the virus that causes COVID-19—can lead to viral variants that
have altered characteristics. For example, the Delta variant demonstrated increased transmissibility and virulence, while the
Omicron variant demonstrated increased transmissibility. These genetic mutations can potentially change the performance of
a test if the mutation alters the part of the virus that the test is targeting. Mutations can affect all COVID-19 test types and
could result in false results.
According to Food and Drug Administration (FDA) officials, to identify the potential impact of viral mutations on test
performance, FDA began conducting its own analysis of the genetic sequences used by authorized COVID-19 tests in March
2020 using an extensive public genetics database that contains variant sequences from around the world. FDA officials told
us the agency began communicating with the public in January 2021, when FDA issued a safety alert about the potential
impact of viral mutations.
On February 22, 2021, FDA issued guidance to provide test developers with information on evaluating the potential impact of
emerging and future viral genetic mutations on COVID-19 tests. On September 23, 2021, FDA revised the emergency use
authorizations (EUA) of certain authorized molecular, antigen, and serological tests to establish additional conditions of
authorization in response to the continued emergence of new variants of SARS-CoV-2. These additional conditions required
test developers to update their authorized labeling and evaluate the impact of SARS-CoV-2 viral mutations on their test’s
performance. On October 6, 2021, FDA updated its diagnostic EUA templates, which described the information and data
FDA recommended developers include in their EUA request. These new templates specified that test developers should
monitor new and emerging viral mutations and variants that could impact test performance on an ongoing basis. As of
December 31, 2021, FDA told us it had sent 164 letters to test developers containing specific recommendations for test
developers to investigate test performance with regards to specific variants.
Sources: GAO summary of FDA documentation and FDA interviews | GAO-22-104266.
FDA officials told us adverse event reporting requirements apply to both
developers of authorized tests and developers of unauthorized tests that
fell under FDA’s enforcement discretion. Although the adverse event
reporting requirements are the same, FDA’s communication of these
requirements to test developers differs, depending on whether the test is
authorized or unauthorized. Specifically, FDA includes the adverse event
reporting requirements as a condition of authorization in the EUA letter
FDA sends to developers of authorized tests. However, prior to
November 15, 2021, FDA did not explicitly communicate these
requirements to developers of unauthorized tests on a notification list
either through policy documents or email contact with test developers. As
a result, FDA did not have assurance that developers of unauthorized
Page 27 GAO-22-104266 FDA Oversight of COVID-19 Tests
tests on the notification lists were aware of the need to report adverse
events.
We asked FDA officials about the extent to which they had received
adverse event reports for unauthorized tests. Officials told us that they
had identified five adverse event reports associated with these tests as of
September 30, 2021, and attributed this low number to a possible low
overall usage of these tests. It is also possible the low number of adverse
event reports for these unauthorized tests was due to FDA’s unclear
communication about adverse event reporting requirements for tests on a
notification list. FDA officials told us that as a result of conversations
between FDA and GAO during the course of this audit, the agency
revised its COVID-19 test guidance on November 15, 2021 to clearly
communicate adverse event reporting requirements for developers of
tests on notification lists. 53
FDA Has Taken Action to FDA has employed a variety of post-market actions to address identified
Address Test Performance performance problems with a COVID-19 test or violations of the Food,
Drug, and Cosmetic Act by test developers. These actions include the
Problems and Violations
following: safety communications, letters to clinical laboratory staff and
health care providers, warning letters, recalls, EUA revocations, and
import alerts. FDA officials told us that if a potential concern with a
COVID-19 test is found, FDA evaluates the risk to patients and the public
posed by a test’s issues to determine an appropriate action. According to
FDA officials, the agency will first attempt to resolve concerns with a test
developer to address its concerns in a timely manner prior to taking other
action, which could include communicating with the public about safety or
performance issues. If the test developer cannot address FDA’s concerns
in a timely manner, then FDA may choose to use one of the options noted
above. According to FDA’s website and FDA officials, the agency took the
following actions as of December 31, 2021. (See table.)
53Food and Drug Administration, Policy for Coronavirus Disease-2019 Tests During the
Public Health Emergency (Revised), Nov. 15, 2021. In this guidance, FDA stated that test
developers with an unauthorized test on a notification list are expected to comply with
medical device reporting requirements.
Page 28 GAO-22-104266 FDA Oversight of COVID-19 Tests
Table 1: FDA’s Reported Actions to Monitor COVID-19 Tests as of December 31,
2021
Type of FDA Action Number of Actions
Safety Communication 5
Letter to Clinical Laboratory Staff and Health 10
Care Providers
Warning Letter 33
Recall 42
Emergency Use Authorization Revocation 16
Import Alert 348
Source: GAO analysis of Food and Drug Administration Information. | GAO-22-104266
• Safety communications. FDA issued five safety communications for
COVID-19 tests. In a safety communication, FDA describes
appropriate actions that patients, consumers, and health care
providers should take to reduce risk. According to FDA officials, a
safety communication’s audience is intended to be a lay user when
there is an important message for the public. For example, FDA
issued a safety communication in May 2021 to advise the public and
health care providers to avoid the use of antibody tests to evaluate a
person’s level of immunity from COVID-19. FDA may also issue a
safety communication when a test has an increased risk of false
results.
• Letters to clinical laboratory staff and health care providers. FDA
issued ten letters to clinical laboratory staff and health care providers
related to COVID-19 tests. FDA posts these letters on its website to
inform clinical laboratory staff and health care providers about safety
concerns with these tests. In these letters, FDA makes
recommendations about the appropriate use of COVID-19 tests and
alerts clinical laboratory staff and health care providers about potential
safety issues with COVID-19 tests that require awareness when
performing the test.
According to FDA officials, the audience of these letters is intended to
be a technical audience; therefore, such a letter is used when the
message is more appropriate for laboratory staff, such as when it is
related to the steps used to perform a test in a laboratory. For
example, in November 2020, FDA issued a letter recommending that
clinical laboratory staff and health care providers only use antigen
tests with symptomatic individuals because of the potential for false
positive results when antigen tests were used with asymptomatic
individuals. In another letter from April 2020, FDA advised health care
Page 29 GAO-22-104266 FDA Oversight of COVID-19 Tests
providers to avoid using the results of antibody tests as the sole basis
to diagnose COVID-19, as this information only indicates whether a
person may have been exposed to SARS-CoV-2. In addition, FDA
issued another letter in October 2021 regarding the potential for false
positive results with two COVID-19 tests unless software was
updated. 54
• Warning letters. FDA issued 33 warning letters to manufacturers or
distributors of products intended to diagnose or identify antibodies for
COVID-19, and ten warning letters for products claiming to diagnose
COVID-19 through body temperature. According to FDA officials, if
FDA finds that a test developer has violated the Federal Food, Drug,
and Cosmetic Act or FDA regulations, FDA may initiate an
investigation. FDA officials told us that FDA’s post-market monitoring
team may work with FDA’s fraud team and FDA’s pre-market review
team during this investigation. After an investigation, FDA may notify
the manufacturer of any statutory violations it found with a warning
letter. A warning letter identifies the violation, such as COVID-19 tests
offered for sale without marketing approval, clearance, or
authorization from FDA. A warning letter also makes clear that the
company should correct the problem and provides directions and a
time frame for the company to inform FDA of its plans for correction.
FDA then monitors to ensure that the company’s corrections are
adequate. If the company fails to address the violation, FDA may take
enforcement action.
According to FDA officials, the agency may also communicate with
test developers who are in violation of the Federal Food, Drug, and
Cosmetic Act or FDA regulations without formally issuing a warning
letter. According to FDA officials, as of September 30, 2021, FDA’s
interactions with test developers resulted in 202 instances in which
test developers removed language that falsely indicated a test was
FDA approved or withdrew their tests from the market without
additional FDA action, such as issuing a warning letter or revoking an
EUA.
• Recalls. Test developers issued 42 recalls for COVID-19 tests. FDA
uses the term recall when a test developer makes a correction to or
54Food and Drug Administration, Potential for False Positive Results with Abbott Molecular
Inc. Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits - Letter to Clinical
Laboratory Staff and Health Care Providers, accessed Feb. 2, 2022,
https://www.fda.gov/medical-devices/letters-health-care-providers/potential-false-positive-
results-abbott-molecular-inc-alinity-m-sars-cov-2-amp-and-alinity-m-resp-4.
Page 30 GAO-22-104266 FDA Oversight of COVID-19 Tests
removes a product from the market that is in violation of the Federal
Food, Drug, and Cosmetic Act. Recalls occur when necessary to
protect the public health, such as when a product presents a risk of
injury or is defective. For example, one test developer recalled its
antibody and antigen tests in April 2021 due to the likely risk of false
results, and because neither test was authorized by FDA for
distribution. Four out of the 42 recalls were Class I, which is the most
serious type of recall because there is a reasonable probability that
the use of a product will cause serious adverse health consequences
or death.
When a test developer learns that its product violates the law, it is
expected to do two things: (1) initiate a recall, and (2) notify the FDA.
To initiate a voluntary recall, a test developer provides FDA with key
information, such as the reason for the recall and contact information
for its customers and users who purchased the device. The test
developer may be asked to provide FDA with information, such as the
reason for the correction or removal of the device, an assessment of
the health hazard associated with the device, and the volume of
product in distribution and proposed strategy for conducting the recall.
If a company fails to recall a medical device, such as a COVID-19
test, that is associated with significant health problems or death, FDA
can require a company to recall the device. However, in practice, the
FDA has rarely needed to require a medical device recall. Nearly all
medical device recalls are voluntarily initiated by a device
manufacturer. FDA’s role is generally to oversee a firm’s management
of a recall.
• Import alerts. FDA officials told us FDA had placed 348 tests from
248 firms on Import Alert. According to FDA, the agency may detain at
the border and refuse to allow the import of tests that appear to violate
the Federal Food, Drug, and Cosmetic Act, including foreign tests that
do not have appropriate labeling, are unauthorized at-home tests, or
are fraudulent. 55 FDA officials told us the agency also places tests on
Import Alert when FDA has denied or declined to issue an EUA
request or when the developer has withdrawn their EUA request.
• EUA revocations. FDA revoked 16 EUAs for COVID-19 tests as of
December 31, 2021. FDA may revoke an EUA if the declaration of
emergency under the Federal Food, Drug, and Cosmetic Act or threat
55According to FDA officials, import alerts notify FDA staff and the public that FDA has
sufficient information to detain certain products without physical examination because they
appear to be in violation of the FD&C Act (actual violation need not be established).
Page 31 GAO-22-104266 FDA Oversight of COVID-19 Tests
justifying emergency use authorization no longer exists, when the
agency concludes that the statutory criteria for issuance of an EUA
are no longer met, or when other circumstances make revocation of
an EUA appropriate to protect public health or safety. For example,
FDA may revoke an EUA based on performance concerns about a
test, or, according to FDA officials, when a developer requests the
EUA for their test be revoked.
Of the 16 EUAs FDA has revoked, two were revoked for poor
antibody test performance. For example, according to FDA officials,
FDA revoked the EUA for an antibody test in the summer of 2020,
after FDA analyzed new data and determined it was no longer
reasonable to believe that the test may be effective in detecting
antibodies against SARS-CoV-2 or that the known and potential
benefits of the test outweighed the known and potential risks.
FDA revoked the remaining 14 EUAs either because a test was
converted to full FDA marketing authorization (1 test), or the test
developer requested that FDA revoke the EUA (13 tests). Some of
these test developers requested that FDA revoke an EUA because a
certain COVID-19 test was no longer in use. (See text box, below, for
additional information about FDA authorization of COVID-19 tests for
use after the public health emergency ends.)
Authorization of COVID-19 Tests for Use after the Public Health Emergency Ends
As of December 31, 2021, the Food and Drug Administration (FDA) had granted full marketing authorization to two COVID-
19 tests that enabled them to be marketed beyond the emergency declaration. In order to grant full marketing authorization
for this test, FDA reviewed additional validation data beyond what was needed for an EUA.
To help device manufacturers prepare for the eventual termination of the COVID-19 public health emergency, FDA issued
draft guidance on December 22, 2021, titled, Transition Plan for Medical Devices Issued Emergency Use Authorizations
(EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Draft Guidance for Industry and Food
and Drug Administration Staff. This draft guidance was intended to, among other things, describe FDA’s recommendations
for medical device manufacturers, including COVID-19 test developers, on how to transition from EUA to full marketing
authorization in order to continue distributing their tests after the emergency declaration ends.
Source: GAO summary of FDA information. | GAO-22-104266
FDA Shifted Resources to FDA officials told us they have been able to adequately conduct post-
Conduct Post-Market market monitoring of COVID-19 tests, but, similar to reviewing EUA
requests, had to shift resources from other areas in order to do so.
Monitoring of COVID-19
Officials told us that FDA had been challenged by the increasing volume
Tests of adverse event reports for tests, and by an increase in the number of
allegations of fraudulent tests being distributed outside their EUAs. FDA
officials told us there was also an increase in reporting of adverse events
Page 32 GAO-22-104266 FDA Oversight of COVID-19 Tests
to the Electronic Medical Device Reporting system by test developers
during this emergency as well.
To address the increase in adverse event reports, FDA officials told us
the agency increased the number of staff on the post-market monitoring
team for COVID-19 tests. According to FDA officials, this team was
composed of eight staff early in the pandemic, as of the second quarter of
2020. To supplement these existing staff, FDA reassigned 12 additional
staff in 2020 to assist the existing team. According to FDA officials, these
staff reassignments negatively affected FDA’s post-market surveillance
for other products. According to FDA officials, reassigned staff had to
deprioritize their previous workload, which led to shortfalls in non-COVID
recall work, among other areas. Officials told us that some of the 12
reassigned staff will become permanent, and others have been gradually
reassigned back to their previous FDA divisions.
FDA officials said they also hired four additional staff for the COVID-19
test post-market monitoring team. During the pandemic response, two
staff members left this FDA team; thus, the team had a net gain of two
full-time equivalent employees aside from the 12 reassigned staff.
According to FDA officials, these two additional staff allowed the team to
conduct post-market monitoring reviews of COVID tests in more detail.
Additionally, to help FDA address the high volume of adverse event
reports for tests during the public health emergency, this FDA team
automated some of the internal processes to compile adverse event
information.
FDA officials told us the agency has submitted a proposal to HHS
requesting to hire additional staff to implement an initiative that would,
among other goals, help identify COVID-19 test performance problems in
real time using real-world data. This initiative is called Semantic
Harmonization and Interoperability Enhancement for Laboratory Data. 56
The purpose of the initiative is to improve the quality, interoperability,
portability, and utility of laboratory data and evaluate the real-world
performance of SARS-CoV-2 diagnostic and antibody tests. FDA officials
told us that FDA is currently able to use laboratory data on COVID-19
tests for surveillance to identify outliers in terms of test performance for
56Semantic Harmonization and Interoperability Enhancement for Laboratory Data was
established in 2019 and is a multistakeholder collaboration to improve the quality,
interoperability and portability of laboratory data within and between institutions so that
diagnostic information can be drawn from different sources or shared between institutions.
Page 33 GAO-22-104266 FDA Oversight of COVID-19 Tests
specific COVID-19 test brands. 57 FDA officials told us that, with more
resources, the initiative could integrate existing laboratory data with
patient data from electronic health records to see how test results align
with patient diagnoses and outcomes.
Testing is a critical tool in our nation’s fight against COVID-19 and FDA
Conclusions took steps to increase the availability of tests early in the pandemic when
there was an urgent need for tests. This included issuing policies that
enabled certain types of tests to be used prior to FDA review of their
accuracy and reliability. However, once hundreds of tests were reviewed
and authorized for emergency use, the risks of unauthorized tests being
used outweighed the benefits. FDA eventually took action to mitigate this
risk in the current pandemic. However, until FDA develops a policy for the
use of enforcement discretion regarding unauthorized tests in a future
public health emergency—including the conditions under which FDA
would begin and end such discretion—the agency could face the risk that
unauthorized tests could be used for an extended period of time, even
when a sufficient number of authorized tests are available. This could
hamper an effective response and recovery during a future crisis.
The Commissioner of FDA should develop a policy for the use of
Recommendation for enforcement discretion regarding unauthorized tests in future public
Executive Action health emergencies. This policy should include the conditions under
which FDA would begin and end the use of such discretion.
(Recommendation 1)
We provided a draft of this report to HHS for review. In its comments,
Agency Comments reproduced in appendix IV, HHS concurred with our recommendation and
also stated that FDA did not permit the use of unauthorized tests but
instead exercised enforcement discretion to not object to their use. HHS
also described some lessons learned from the COVID-19 pandemic that it
said could enable faster authorization of tests during a future public health
emergency. HHS also provided technical comments, which we
incorporated as appropriate.
We are sending copies of this report to the appropriate congressional
committees, the Secretary of Health and Human Services and the
57The CARES Act included a provision requiring laboratories to submit the result of each
COVID-19 test to the Secretary of Health and Human Services in a manner specified by
the Secretary. Pub. L. No. 116-136, div. B, § 18115, 134 Stat. 281, 574 (2020).
Page 34 GAO-22-104266 FDA Oversight of COVID-19 Tests
Commissioner of FDA. In addition, the report is available at no charge on
the GAO website at http://www.gao.gov.
If you or your staff have any questions about this report, please contact
Mary Denigan-Macauley at 202-512-7114 or
DeniganMacauleyM@gao.gov. Contact points for our Offices of
Congressional Relations and Public Affairs may be found on the last page
of this report. GAO staff who made major contributions to this report are
listed in appendix V.
Mary Denigan-Macauley
Director, Health Care
Page 35 GAO-22-104266 FDA Oversight of COVID-19 Tests
List of Addressees
The Honorable Patrick Leahy
Chairman
The Honorable Richard Shelby
Vice Chairman
Committee on Appropriations
United States Senate
The Honorable Ron Wyden
Chairman
The Honorable Mike Crapo
Ranking Member
Committee on Finance
United States Senate
The Honorable Patty Murray
Chair
The Honorable Richard Burr
Ranking Member
Committee on Health, Education, Labor, and Pensions
United States Senate
The Honorable Gary C. Peters
Chairman
The Honorable Rob Portman
Ranking Member
Committee on Homeland Security and Governmental Affairs
United States Senate
The Honorable Kyrsten Sinema
Chair
The Honorable James Lankford
Ranking Member
Subcommittee on Government Operations and Border Management
Committee on Homeland Security and Governmental Affairs
United States Senate
Page 36 GAO-22-104266 FDA Oversight of COVID-19 Tests
The Honorable Rosa L. DeLauro
Chair
The Honorable Kay Granger
Ranking Member
Committee on Appropriations
House of Representatives
The Honorable Frank Pallone, Jr.
Chairman
The Honorable Cathy McMorris Rodgers
Republican Leader
Committee on Energy and Commerce
House of Representatives
The Honorable Bennie G. Thompson
Chairman
The Honorable John Katko
Ranking Member
Committee on Homeland Security
House of Representatives
The Honorable Carolyn B. Maloney
Chairwoman
The Honorable James Comer
Ranking Member
Committee on Oversight and Reform
House of Representatives
The Honorable Richard E. Neal
Chairman
The Honorable Kevin Brady
Republican Leader
Committee on Ways and Means
House of Representatives
The Honorable Abigail D. Spanberger
House of Representatives
Page 37 GAO-22-104266 FDA Oversight of COVID-19 Tests
Appendix I: Additional FDA Actions to Help
Appendix I: Additional FDA Actions to Help
Increase Access to COVID-19 Tests
Increase Access to COVID-19 Tests
In addition to the actions described earlier in this report, the Food and
Drug Administration (FDA) took additional actions during the pandemic to
help increase access to COVID-19 tests.
FDA Authorization of Tests Because of the lack of availability of natural viral material early in the
Based on Data from pandemic, FDA authorized tests that used contrived samples—which are
made from viral material that may come from a range of sources—to
Contrived Samples
validate test performance from February through mid-May 2020.
According to FDA, test developers experienced challenges obtaining the
viral material needed for test validation early in the pandemic. 1 Once
positive patient samples became more widely available in April and May
2020, FDA began recommending test developers to validate their tests
using patient specimens, and required developers of tests that had
previously been authorized using contrived material to conduct post-
authorization validation studies using patient specimens. According to
FDA, the agency authorized 59 COVID-19 tests that had been validated
using contrived viral material.
FDA Authorization of Tests In June 2020, FDA issued updated emergency use authorization (EUA)
Intended for Screening templates outlining expectations for the validation of tests for screening
asymptomatic individuals. Then, on March 16, 2021, FDA announced it
was providing information for test developers about a streamlined path to
authorization for tests intended for screening asymptomatic individuals in
a serial manner, including tests that could be used at-home and
purchased over-the-counter. 2 According to FDA, serial testing involves
testing the same individual multiple times within a few days, and can
1According to FDA, live virus was listed as available to developers with Biosafety Level-3
capabilities on or about February 6, 2020 from the Biodefense and Emerging Infections
Research Resources Repository and on or about February 18, 2020 from the University of
Texas Medical Branch. However, most test developers do not have Biosafety Level-3
capabilities. To address the needs of these developers, after conducting testing to ensure
that the viral material did not contain any infectious viral particles, these entities produced
lots of viral material for developers’ use by late February. FDA supported federal
government efforts to prioritize the first distribution of viral material to developers working
on assays that already had FDA-cleared platforms in U.S. health care centers. FDA also
proactively contacted many other developers with whom it had engaged to connect those
in need of viral material with the Biodefense and Emerging Infections Research
Resources Repository.
2Food and Drug Administration, “FDA Statement: Coronavirus (COVID-19) Update: FDA
takes steps to streamline path for COVID-19 screening tools, provides information to help
groups establishing testing programs” (March 16, 2021), accessed Mar. 17, 2021,
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-
takes-steps-streamline-path-covid-19-screening-tools-provides.
Page 38 GAO-22-104266 FDA Oversight of COVID-19 Tests
Appendix I: Additional FDA Actions to Help
Increase Access to COVID-19 Tests
increase chances of detecting asymptomatic infection that might not be
identified with a single test. FDA announced that in certain circumstances,
a point-of-care or at-home test could be authorized for use without the
need for validating its use in asymptomatic individuals prior to
authorization. 3 FDA stated that it made this change to further expand the
availability of tests authorized for screening asymptomatic individuals and
increase consumer access to testing.
To increase access to over-the-counter at-home tests, on October 25,
2021, FDA further revised the path to authorization. Specifically, FDA
announced that developers of those tests could request authorization to
add single-use testing for individuals experiencing COVID-19 symptoms
without needing to submit additional data to FDA. According to the
Department of Health and Human Services (HHS), this change would
allow for manufacturers of these tests to sell the tests singly, rather than
in packs of two tests, potentially at a lower price. On the same day, HHS
announced the creation of the Independent Test Assessment Program at
the National Institutes of Health (NIH). Through this program, experts
from NIH, HHS, and the Centers for Disease Control and Prevention
(CDC) conducted studies, supported test developers, and provided data
for FDA to use when evaluating the tests. HHS stated that the program
prioritized new over-the-counter tests with the potential to be
manufactured at significant scale. As of April 13, 2022, FDA had
authorized five tests that had participated in this program.
3FDA stated in the press announcement the agency’s belief that evidence of a test’s
strong performance in symptomatic patients combined with serial testing can mitigate the
risk of false results when testing asymptomatic individuals. Food and Drug Administration,
“FDA Statement: Coronavirus (COVID-19) Update: FDA takes steps to streamline path for
COVID-19 screening tools, provides information to help groups establishing testing
programs” (Mar. 16, 2021).
Page 39 GAO-22-104266 FDA Oversight of COVID-19 Tests
Appendix II: Summary of Key FDA and HHS Appendix II: Summary of Key FDA and HHS
Policies That Guided the Regulation of COVID-
Policies That Guided the Regulation of
19 Tests
COVID-19 Tests
Table 2: Key FDA and HHS Policies for the Regulation of COVID-19 Tests
Date Description of Policy
February 29, 2020 FDA issued a policy stating that FDA did not intend to object to laboratories using their diagnostic
laboratory developed tests (LDTs) prior to authorization when the laboratories validated their tests,
notified FDA, and submitted an emergency use authorization (EUA) request to FDA within 15
business days after notification.a
March 16, 2020 FDA issued a policy stating that FDA did not intend to object to commercial manufacturers
developing and distributing their diagnostic tests prior to authorization where the manufacturers
validated their tests, notified FDA, and submitted an EUA request to FDA within 15 business days
after notification.b,c
FDA issued a policy stating that FDA did not expect developers of antibody tests, including
commercial manufacturers and laboratories, to seek an EUA for these antibody tests where the
developers validated their tests, notified FDA, and included certain information in the test
reports.c,d
FDA issued a policy stating that FDA did not intend to object to states and territories authorizing
laboratories within their state or territory to develop and use their own COVID-19 LDTs.c
May 4, 2020 FDA issued a policy modifying its previous policy for antibody tests stating that commercial
manufacturers of antibody tests were expected to submit an EUA request to FDA within 10
business days after notification or the date on which the guidance was published.e
August 19, 2020 HHS announced a policy under which FDA would no longer require premarket review for LDTs,
absent notice and comment rulemaking.f
March 16, 2021 FDA announced it had taken steps to help streamline the path to authorization for tests intended
for screening asymptomatic individuals in a serial manner, including tests that could be used at-
home and purchased over-the-counter.g
November 15, 2021 HHS withdrew its August 2020 policy under which FDA would not require premarket review for
LDTs, thereby reinstating FDA’s approach to regulating COVID-19 LDTs.h
FDA issued a policy stating that the agency generally expected COVID-19 tests to have been
issued an EUA prior to the tests being distributed or offered, that FDA would no longer add
commercial or laboratory developed tests to the notification lists, and that FDA no longer intended
to apply the March 16, 2020 policy to additional states or territories to authorize laboratories within
that state or territory to develop and use their own COVID-19 tests. FDA also expected
laboratories offering LDTs without submission of an EUA request to submit an EUA request to
FDA within 60 calendar days from the date of issuance of the updated guidance or to cease
marketing and offering their LDT.i
Source: GAO summary of guidance and announcements from the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS). │GAO-22-104266
a
Department of Health and Human Services, Food and Drug Administration, Policy for Diagnostic
Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency
Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency (Immediately In
Effect Guidance for Clinical Laboratories and Food and Drug Administration Staff) (Silver Spring, Md.:
Feb. 29, 2020).
b
FDA recommended manufacturers post on their websites the test’s instructions for use and data
about test performance characteristics.
c
Department of Health and Human Services, Food and Drug Administration, Policy for Diagnostic
Tests for Coronavirus Disease-2019 during the Public Health Emergency (Immediately In Effect
Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration
Staff) (Silver Spring, Md.: Mar. 16, 2020).
d
FDA recommended developers of antibody tests include certain information in test reports, such as
statements that the test had not been reviewed by FDA and that results from antibody testing should
not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection.
Page 40 GAO-22-104266 FDA Oversight of COVID-19 Tests
Appendix II: Summary of Key FDA and HHS
Policies That Guided the Regulation of COVID-
19 Tests
e
Department of Health and Human Services, Food and Drug Administration, Policy for Coronavirus
Disease-2019 Tests During the Public Health Emergency (Revised) (Immediately In Effect Guidance
for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff) (Silver
Spring, Md.: May 4, 2020).
f
Department of Health and Human Services, “Rescission of Guidances and Other Informal Issuances
Concerning Premarket Review of Laboratory Developed Tests,” (Aug. 19, 2020), accessed Aug. 20,
2020, https://www.hhs.gov/coronavirus/testing/recission-guidances-informal-issuances-premarket-
review-lab-tests/index.html.
g
Food and Drug Administration, “FDA Statement: Coronavirus (COVID-19) Update: FDA takes steps
to streamline path for COVID-19 screening tools, provides information to help groups establishing
testing programs” (March 16, 2021), accessed Mar. 17, 2021, https://www.fda.gov/news-
events/press-announcements/coronavirus-covid-19-update-fda-takes-steps-streamline-path-covid-19-
screening-tools-provides.
h
Department of Health and Human Services, “Statement by HHS Secretary Xavier Becerra on
Withdrawal of HHS Policy on Laboratory-Developed Tests” (Nov. 15, 2021), accessed Nov. 16, 2021,
https://www.hhs.gov/about/news/2021/11/15/statement-hhs-secretary-xavier-becerra-withdrawal-hhs-
policy-laboratory-developed-tests.html.
Department of Health and Human Services, Food and Drug Administration, Policy for Coronavirus
i
Disease-2019 Tests During the Public Health Emergency (Revised) (Immediately In Effect Guidance
for Developers and Food and Drug Administration Staff) (Silver Spring, Md.: Nov. 15, 2021).
Page 41 GAO-22-104266 FDA Oversight of COVID-19 Tests
Appendix III: Additional FDA Actions to
Appendix III: Additional FDA Actions to
Support COVID-19 Test Developers
Support COVID-19 Test Developers
The Food and Drug Administration (FDA) took several actions during the
pandemic to support COVID-19 test developers and assist them as they
developed their tests.
• FDA developed EUA templates. FDA developed emergency use
authorization (EUA) templates to help guide test developers as they
developed their tests and prepared their EUA requests. 1 According to
FDA officials, the first EUA template for test developers was available
to test developers by request in January 2020, and later posted on
FDA’s website on February 29, 2020. 2 According to FDA officials,
FDA had shared the template with over 100 laboratory and
commercial manufacturer developers by the end of February 2020.
As of November 2021, eight EUA templates were available on FDA’s
website. 3 The templates varied by factors such as the type of test and
setting for use of the test; officials told us the agency updated, added,
and removed templates as necessary to support developers of
COVID-19 tests. These templates described the information and data
FDA recommended developers include in their EUA request, the
types and sizes of validation studies FDA recommended developers
conduct to demonstrate the test’s performance, and recommended
minimum clinical performance standards. 4 Representatives from one
association we spoke with told us the EUA templates were very useful
because they showed what types of data FDA was looking for and
helped developers know what they needed to focus on to be
successful with their EUA request.
1Test developers were not required to use the EUA templates. FDA encouraged
developers who intended to use alternative approaches to consider seeking FDA’s
feedback or recommendations to help them through the EUA process.
2FDA officials stated that FDA posted a statement on its website regarding the template’s
availability on January 27, 2020.
3According to FDA officials, 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 developers of COVID-19 tests.
4For example, FDA recommended that certain types of validation studies be conducted for
SARS-CoV-2 molecular diagnostic assays, including a limit of detection study and a cross-
reactivity study. Limit of detection is the minimum amount of target in a sample that a test
can accurately measure. Cross-reactivity studies are performed to demonstrate that the
test does not react with other pathogens, disease agents, or flora that are reasonably
likely to be encountered in a clinical specimen. FDA also recommended that validation
studies include data from at least 30 suspected-positive and 30 negative clinical samples.
Page 42 GAO-22-104266 FDA Oversight of COVID-19 Tests
Appendix III: Additional FDA Actions to
Support COVID-19 Test Developers
• FDA engaged with test developers through the pre-EUA process.
Test developers could submit a pre-EUA request or communicate with
FDA via email prior to submission of an EUA request. The pre-EUA
process allowed FDA scientific and technical subject matter experts to
help facilitate the submission of a complete EUA request. FDA
officials told us pre-EUA submissions could also assist in the
development of conditions of authorization, fact sheets, and other
documentation that would be needed for an EUA. FDA received 1,275
pre-EUA requests for COVID-19 tests between January 2020 and
September 2021, according to FDA officials. 5 Representatives from
two associations we spoke with told us that some members found the
pre-EUA process to be useful. However, some test developers from
one of these associations felt it added to the length of time to develop
an EUA request and some wished the process was more transparent.
• FDA held regular public conference calls. Beginning March 25,
2020, FDA held weekly or biweekly public Town Hall teleconference
calls with test developers to communicate recent updates and to
answer questions about the development and validation of COVID-19
tests. As of September 30, 2021, the FDA had held 70 town halls for
COVID-19 test developers.
• FDA posted frequently asked questions on its website. FDA
updated its website with answers to frequently asked questions that
test developers could refer to about the development and
performance of COVID-19 tests, uses for different types of tests,
settings where they can be used, FDA’s priorities for reviewing EUA
requests, and review times, among other topics.
• FDA supplied panels of viral material to test developers.
Beginning in May 2020, FDA supplied a reference panel, which
contained strains of inactivated virus, to developers of molecular tests
to meet a condition of authorization requiring EUA holders to assess
their assay performance with an FDA-recommended reference
material. Use of this reference panel allowed FDA to more accurately
compare the performance of different molecular tests to each other.
Representatives from one association told us that the reference panel
was helpful to some developers.
• Collaborated with the National Institutes of Health (NIH). FDA
officials told us they have worked closely with NIH on the Rapid
Acceleration of Diagnostics (RADx) program, which aims to speed the
development of innovative COVID-19 tests. According to officials,
5According to FDA, a pre-EUA package contained data and information about the safety,
quality, and efficacy of the product and its intended use.
Page 43 GAO-22-104266 FDA Oversight of COVID-19 Tests
Appendix III: Additional FDA Actions to
Support COVID-19 Test Developers
FDA meets regularly with RADx participants to answer questions and
provide feedback on validation plans. Officials told us that as of
February 2022, FDA had authorized over 30 tests that participated in
RADx programs. These tests included over-the-counter at-home tests,
point-of-care tests, high throughput laboratory-based tests, and tests
that detect multiple viruses, many of which include novel technologies.
Page 44 GAO-22-104266 FDA Oversight of COVID-19 Tests
Appendix IV: Comments from the
Appendix IV: Comments from the Department
of Health and Human Services
Department of Health and Human Services
Page 45 GAO-22-104266 FDA Oversight of COVID-19 Tests
Appendix IV: Comments from the Department
of Health and Human Services
Page 46 GAO-22-104266 FDA Oversight of COVID-19 Tests
Appendix V: GAO Contact and Staff
Appendix V: GAO Contact and Staff
Acknowledgments
Acknowledgments
Mary Denigan-Macauley at (202) 512-7144 or
GAO Contact DeniganMacauleyM@gao.gov
In addition to the named contact above, Tom Conahan, Assistant
Staff Director; Laura Tabellion, Analyst-In-Charge; Margot Bolon; Carolyn
Acknowledgments Garvey; and Cathy Whitmore made key contributions to this report. Also
contributing were George Bogart, Sandra George, Vikki Porter, Jeffrey
Tamburello, Janet Wilson, and Chris Zakroff.
(104266)
Page 47 GAO-22-104266 FDA Oversight of COVID-19 Tests
The Government Accountability Office, the audit, evaluation, and investigative
GAO’s Mission arm of Congress, exists to support Congress in meeting its constitutional
responsibilities and to help improve the performance and accountability of the
federal government for the American people. GAO examines the use of public
funds; evaluates federal programs and policies; and provides analyses,
recommendations, and other assistance to help Congress make informed
oversight, policy, and funding decisions. GAO’s commitment to good government
is reflected in its core values of accountability, integrity, and reliability.
The fastest and easiest way to obtain copies of GAO documents at no cost is
Obtaining Copies of through our website. Each weekday afternoon, GAO posts on its website newly
GAO Reports and released reports, testimony, and correspondence. You can also subscribe to
GAO’s email updates to receive notification of newly posted products.
Testimony
Order by Phone The price of each GAO publication reflects GAO’s actual cost of production and
distribution and depends on the number of pages in the publication and whether
the publication is printed in color or black and white. Pricing and ordering
information is posted on GAO’s website, https://www.gao.gov/ordering.htm.
Place orders by calling (202) 512-6000, toll free (866) 801-7077, or
TDD (202) 512-2537.
Orders may be paid for using American Express, Discover Card, MasterCard,
Visa, check, or money order. Call for additional information.
Connect with GAO on Facebook, Flickr, Twitter, and YouTube.
Connect with GAO Subscribe to our RSS Feeds or Email Updates. Listen to our Podcasts.
Visit GAO on the web at https://www.gao.gov.
Contact FraudNet:
To Report Fraud,
Website: https://www.gao.gov/about/what-gao-does/fraudnet
Waste, and Abuse in
Automated answering system: (800) 424-5454 or (202) 512-7700
Federal Programs
A. Nicole Clowers, Managing Director, ClowersA@gao.gov, (202) 512-4400, U.S.
Congressional Government Accountability Office, 441 G Street NW, Room 7125, Washington,
Relations DC 20548
Chuck Young, Managing Director, youngc1@gao.gov, (202) 512-4800
Public Affairs U.S. Government Accountability Office, 441 G Street NW, Room 7149
Washington, DC 20548
Stephen J. Sanford, Managing Director, spel@gao.gov, (202) 512-4707
Strategic Planning and U.S. Government Accountability Office, 441 G Street NW, Room 7814,
External Liaison Washington, DC 20548
Please Print on Recycled Paper.
File and source
- File
- 22-104266-covid-19-fda-took-steps-to-help.pdf
- Size
- 980,294 bytes
- SHA-256
- 1ce2a2a1f6ae8af64383732a85f969b3825f4ff6073a871e91be568e1a78b6a1
- Original
- www.gao.gov