Lucira by Pfizer COVID-19 & Flu Home Test, EUA Letter — FDA to Pfizer Inc., EUA220490 (June 15, 2023)
Summary
A letter from the Food and Drug Administration dated June 15, 2023, addressed to Pfizer Inc. and signed by Jeffrey E. Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health, reissuing the Emergency Use Authorization for the Lucira by Pfizer COVID-19 & Flu Home Test, EUA Number EUA220490. The letter explains that the original EUA was issued February 24, 2023 at Lucira Health, Inc.'s request and that Pfizer requested an amendment on April 19, 2023. Listed revisions include transferring ownership of the EUA to Pfizer Inc., renaming the device and extending the shelf life claim from 9 months to 12 months. The letter sets out the criteria for issuance, the scope of authorization for non-prescription home use with anterior nasal swab samples, the conditions of authorization and the duration of the authorization.
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“Lucira by Pfizer COVID-19 & Flu Home Test, EUA Letter — FDA to Pfizer Inc., EUA220490 (June 15, 2023).”
Original at www.fda.gov. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/fda-lucira-by-pfizer-covid-flu-home-test-factsheet-67d7568793/
, SHA-256 bc8ed82595ae42834d9add37a9aba0814421553fcd5018b0462e97bc37a9a9ee.Full text
June 15, 2023
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Elizabeth Mauro
Director, Global Regulatory Science
Pfizer Inc.
66 Hudson Boulevard East
New York, NY 10001
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Device: Lucira by Pfizer COVID-19 & Flu Home Test
EUA Number: EUA220490
Company: Pfizer Inc.
Indication: This test is authorized for the simultaneous qualitative detection
and differentiation of SARS-CoV-2, influenza A, and influenza B
viral nucleic acid. This test is authorized for non-prescription home
use with anterior nasal swab samples from individuals 14 years or
older (self-collected) or individuals 2 years or older (collected by
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an adult) with signs and symptoms consistent with a respiratory
tract infection including COVID-19.
Dear Elizabeth Mauro:
On February 24, 2023, based on Lucira Health, Inc.’s request, the Food and Drug
Administration (FDA) issued an Emergency Use Authorization (EUA) for emergency use of the
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Lucira COVID-19 & Flu Home Test, pursuant to Section 564 of the Federal Food, Drug, and
Cosmetic Act (the Act) (21 U.S.C. §360bbb-3) for the indication stated in the letter.1 In
addition, based on Lucira Health, Inc.’s request, FDA also granted updates to the authorized
labeling on March 22, 2023.2
.
On April 19, 2023 you3 requested that FDA amend your EUA. Based on that request, and
having concluded that revising the February 24, 2023, EUA is appropriate to protect the public
1
The February 24, 2023, letter authorized the Lucira COVID-19 & Flu Home Test for the simultaneous qualitative
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detection and differentiation of SARS-CoV-2, influenza A, and influenza B viral nucleic acid. This test is authorized
for non-prescription home use with anterior nasal swab samples from individuals 14 years or older (self-collected) or
individuals 2 years or older (collected by an adult) with signs and symptoms consistent with a respiratory tract
infection including COVID-19.
2
On March 22, 2023, Lucira Health, Inc.’s request was granted to update the Instructions for Use of the Lucira
COVID-19 & Flu Home Test to: (1) extend the product shelf life claim from 6 months to 9 months when stored at
15-30°C, based on the results of your completed stability studies, and (2) provide clarifications to the clinical study
description.
3
For ease of reference, this letter will use the term “you” and related terms to refer to Pfizer Inc.
Page 2 –Elizabeth Mauro, Pfizer Inc.
health or safety under section 564(g)(2)(C) of the Act (21 U.S.C. § 360bbb-3(g)(2)(C)), FDA is
reissuing the February 24, 2023, letter in its entirety with the revisions incorporated.4 Pursuant
to section 564 of the Act and the Scope of Authorization (Section II) and Conditions of
Authorization (Section IV) of this reissued letter, your product5 is now authorized for use
consistent with the indication described above.
On February 4, 2020, as amended on March 15, 2023, pursuant to Section 564(b)(1)(C) of the
Act, the Secretary of the Department of Health and Human Services (HHS) determined that
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there is a public health emergency, or a significant potential for a public health emergency, that
affects, or that has a significant potential to affect, national security or the health and security of
United States citizens living abroad, and that involves the virus that causes COVID-19.
Pursuant to Section 564 of the Act, and on the basis of such determination, the Secretary of
HHS then declared that circumstances exist justifying the authorization of emergency use of in
vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19, subject to
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the terms of any authorization issued under Section 564(a) of the Act.6
FDA considered the totality of scientific information available in authorizing the emergency use
of your product for the indication above. A summary of the performance information FDA
relied upon is contained in the Lucira by Pfizer COVID-19 & Flu Home Test Instructions for
Use.” There is an FDA-approved/cleared test for the qualitative detection and identification of
SARS-CoV-2, influenza A virus, and influenza B virus, along with some other organism types
and subtypes not targeted by your product, but this is not an adequate and available alternative
to your product. Respiratory viral infections caused by the influenza A and B viruses and
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SARS-CoV-2 can have similar clinical presentation and diagnostic considerations. Thus, to
differentially detect SARS-CoV-2, information from a test that detects and differentiates the
virus that causes COVID-19 and the common influenza viruses that cause seasonal epidemics
of flu is needed.
Having concluded that the criteria for issuance of this authorization under Section 564(c) of the
Act are met, I am authorizing the emergency use of your product, described in the Scope of
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Authorization of this letter (Section II), subject to the terms of this authorization.
I. Criteria for Issuance of Authorization
4
The revisions to the February 24, 2023, letter and authorized labeling include: (1) transfering ownership of the
EUA from Lucira Health, Inc. to Pfizer Inc. (2) updating the name of the EUA device from “Lucira COVID-19 &
Flu Home Test” to “Lucira by Pfizer COVID-19 & Flu Home Test,” (2) updating Condition of Authorization Q. in
the February 24, 2023 letter (and below) to make it specific for Influenza B, (3) extending the product shelf life
claim from 9 months to 12 months when stored at 15-30°C based on data provided, and (4) updating the Fact Sheet
for Healthcare Providers and the Letter of Authorization to reflect the updates made and for consistency with
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language used in more recent authorizations.
5
For ease of reference, this letter will use the term “your product” to refer to the Lucira by Pfizer COVID-19 & Flu
Home Test for the indication identified above.
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U.S. Department of Health and Human Services, Determination of a Public Health Emergency and Declaration
that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and
Cosmetic Act, 21 U.S.C. § 360bbb-3. February 4, 2020. 85 FR 7316 (February 7, 2020). U.S. Department of Health
and Human Services, Amended Determination of a Public Health Emergency or Significant Potential for a Public
Health Emergency Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-
3(b). March 15, 2023. 88 FR 16644 (March 20, 2023) (“Amended Determination”).
Page 3 –Elizabeth Mauro, Pfizer Inc.
I have concluded that the emergency use of your product meets the criteria for issuance of an
authorization under Section 564(c) of the Act, because I have concluded that:
1. The SARS-CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this virus;
2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe
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that your product may be effective in diagnosing COVID-19, through the simultaneous
qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and/or
influenza B virus RNA, and that the known and potential benefits of your product when
used for diagnosing COVID-19, outweigh the known and potential risks of your product;
and
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3. There is no adequate, approved, and available alternative to the emergency use of your
product. 7
II. Scope of Authorization
I have concluded, pursuant to Section 564(d)(1) of the Act, that the scope of this authorization is
limited to the indication above.
Authorized Product Details
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Your product is single use (disposable) home test kit intended for simultaneous rapid in vitro
qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B viral
nucleic acid. This test is authorized for non-prescription home use with anterior nasal swab
samples from individuals 14 years or older (self-collected) or individuals 2 years or older
(collected by an adult) with signs and symptoms consistent with a respiratory tract infection
including COVID-19. Clinical signs and symptoms of respiratory viral infection due to SARS-
CoV-2 and influenza can be similar.
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Your product is intended for use in the differential diagnosis of SARS-CoV-2, influenza A, and
influenza B in clinical specimens and is not intended to detect influenza C. SARS-CoV-2,
influenza A, and influenza B viral nucleic acid is generally detectable in anterior nasal swab
samples during the acute phase of infection.
Positive results indicate the presence of viral nucleic acid, but clinical correlation with past
medical history and other diagnostic information is necessary to determine infection status.
Positive results do not rule out bacterial infection or co-infection with other pathogens not
detected by the test. The agent detected may not be the definitive cause of disease. Individuals
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who test positive with your product should self-isolate and seek follow up care with their
physician or healthcare provider as additional testing may be necessary.
Negative results for SARS-CoV-2 and influenza B are presumptive, meaning that they should be
confirmed, if necessary for patient management, with an authorized or cleared molecular test
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No other criteria of issuance have been prescribed by regulation under Section 564(c)(4) of the Act.
Page 4 –Elizabeth Mauro, Pfizer Inc.
performed in a CLIA-certified laboratory that meets requirements to perform high or moderate
complexity tests.
Negative results do not rule out SARS-CoV-2, influenza A, and/or influenza B infection and
should not be used as the sole basis for treatment or other management decisions, including
infection control decisions. Negative results should be considered in the context of current
prevalence of infection, an individual’s recent exposures, history and the presence of clinical
signs and symptoms consistent with respiratory infection. Individuals who test negative and
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continue to experience symptoms of fever, cough and/or shortness of breath may still have a
respiratory infection and should seek follow up care with their healthcare provider.
Individuals should report all results obtained with this product to their healthcare provider for
public health reporting and to receive appropriate medical care. All healthcare providers will
report all test results they receive from individuals who use the authorized product to relevant
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public health authorities in accordance with local, state, and federal requirements using
appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics
(LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by the Centers for Disease Control
and Prevention (CDC).
Your product is performed using anterior nasal swab samples from individuals 2 years or older.
When using your product, the individual performing the test must follow the instructions
provided in the “Lucira by Pfizer COVID-19 & Flu Home Test” Package Insert when collecting
the specimen, running the test procedure and interpreting the results.
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The Lucira by Pfizer COVID-19 & Flu Home Test includes the materials or other authorized
materials (as may be requested under Condition L. and M. below), required to collect the anterior
nasal swab sample and perform the test procedure, as described in the “Lucira by Pfizer COVID-
19 & Flu Home Test Instructions for Use” and the “Lucira by Pfizer COVID-19 & Flu Home
Test” Package Insert.
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Your product includes and is required to have the following control materials, or other
authorized control materials (as may be requested under Condition L. below), that are processed
along with the specimen in the Test Unit. The Positive Internal Control (PIC) and Lysis Internal
Control (LIC) contained within the Test Unit must generate expected signal/results in order for a
test to be considered valid, as outlined in the “Lucira by Pfizer COVID-19 & Flu Home Test
Instructions for Use” and the “Lucira by Pfizer COVID-19 & Flu Home Test” Package Insert.
The labeling entitled, “Lucira by Pfizer COVID-19 & Flu Home Test Instructions for Use,”
“Lucira by Pfizer COVID-19 & Flu Home Test” Package Insert, “Lucira by Pfizer COVID-19 &
Flu Home Test” box labels8, (available at https://www.fda.gov/medical-devices/coronavirus-
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disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-
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“Lucira by Pfizer COVID-19 & Flu Home Test” box labels include boxes for 1 test kit and “Lucira by Pfizer
COVID-19 & Flu Home Test” box labels for additional test kits numbers/options as may be requested, and for
which you receive appropriate authorization, in accordance with Condition M. below. Lucira by Pfizer COVID-19
& Flu Home Test kits numbers/options are described in the “Lucira by Pfizer COVID-19 & Flu Home Test
Instructions for Use.”
Page 5 –Elizabeth Mauro, Pfizer Inc.
euas), and the following fact sheet pertaining to the emergency use, are required to be made
available as set forth in the Conditions of Authorization (Section III), and are collectively
referred to as “authorized labeling”:
· Fact Sheet for Healthcare Professionals9: Pfizer Inc. – Lucira by Pfizer COVID-19
& Flu Home Test
The above described product, when accompanied by the authorized labeling provided as set forth
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in the Conditions of Authorization (Section III), is authorized to be distributed and used under
this EUA, despite the fact that it does not meet certain requirements otherwise required by
applicable federal law.
I have concluded, pursuant to Section 564(d)(2) of the Act, that it is reasonable to believe that
the known and potential benefits of your product, when used consistently with the Scope of
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Authorization of this letter (Section II), outweigh the known and potential risks of your product.
I have concluded, pursuant to Section 564(d)(3) of the Act, based on the totality of scientific
evidence available to FDA, that it is reasonable to believe that your product may be effective in
diagnosing COVID-19, when used consistent with the Scope of Authorization of this letter
(Section II), pursuant to Section 564(c)(2)(A) of the Act.
FDA has reviewed the scientific information available to FDA, including the information
supporting the conclusions described in Section I above, and concludes that your product (as
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described in the Scope of Authorization of this letter (Section II)) meets the criteria set forth in
Section 564(c) of the Act concerning safety and potential effectiveness.
The emergency use of your product under this EUA must be consistent with, and may not
exceed, the terms of this letter, including the Scope of Authorization (Section II) and the
Conditions of Authorization (Section III). Subject to the terms of this EUA and under the
circumstances set forth in the Secretary of HHS's determination under Section 564(b)(1)(C) of
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the Act described above and the Secretary of HHS’s corresponding declaration under Section
564(b)(1) of the Act, your product is authorized for the indication above.
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Note that the information typically found in a Fact Sheet for Individuals is contained in the authorized “Lucira by
Pfizer COVID-19 & Flu Home Test” Package Insert, that will be available to end users as set forth in the Conditions
of Authorization (Section III).
Page 6 –Elizabeth Mauro, Pfizer Inc.
III. Conditions of Authorization
Pursuant to Section 564(e) of the Act, I am establishing the following conditions on this
authorization:
Pfizer Inc. (You) and Authorized Distributor(s)10
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A. Your product must comply with the following labeling requirements pursuant to FDA
regulations: the intended use statement (21 CFR 809.10(a)(2), (b)(2)); adequate
directions for use (21 U.S.C. 352(f)), (21 CFR 809.10(b)(5), (7), and (8)); appropriate
limitations on the use of the device including information required under 21 CFR
809.10(a)(4); and any available information regarding performance of the device,
including requirements under 21 CFR 809.10(b)(12).
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B. You and authorized distributor(s) must make available the “Lucira by Pfizer COVID-
19 & Flu Home Test” Package Insert for your product in the shipped kit using the
“Lucira by Pfizer COVID-19 & Flu Home Test” box label (see Footnote 8) and
electronically available on your website.
C. You and authorized distributor(s) must maintain records of customer complaint files
and report to FDA any significant complaints about usability or deviations from the
established performance characteristics of which you and authorized distributor(s)
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become aware.
D. You and authorized distributor(s) must inform relevant public health authorities of this
EUA, including the terms and conditions herein, and any updates made to your product
and/or the authorized labeling.
E. Through a process of inventory control, you and authorized distributor(s) must maintain
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records of the locations (e.g., pharmacies, doctor’s offices, etc.) to which your product is
distributed and the number of tests distributed to each location.
F. You and authorized distributor(s) must collect information on the performance of your
product and have a process in place to track adverse events, including any occurrence
of false positive or false negative results and significant deviations from the established
performance characteristics of your product of which you become aware and report any
such events to FDA in accordance with 21 CFR Part 803. Serious adverse events,
especially unexpected biosafety concerns, should immediately be reported to the
Division of Microbiology (DMD)/Office of Health Technology 7 (OHT7): Office of In
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Vitro Diagnostics/Office of Product Evaluation and Quality (OPEQ)/Center for
Devices and Radiological Health (CDRH) (via email: CDRH-
EUAReporting@fda.hhs.gov).
“Authorized Distributor(s)” are identified by you, Pfizer Inc., in your EUA submission as an entity allowed to
distribute your product.
Page 7 –Elizabeth Mauro, Pfizer Inc.
G. You and authorized distributor(s) are authorized to make available additional
information relating to the emergency use of your product that is consistent with, and
does not exceed, the terms of this letter of authorization.
H. You and authorized distributor(s) using your product must ensure that any records
associated with this EUA are maintained until otherwise notified by FDA. Such records
must be made available to FDA for inspection upon request.
Pfizer Inc. (You)
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I. You must notify FDA of any authorized distributor(s) of your product, including the
name, address, and phone number of any authorized distributor(s).
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J. You must provide authorized distributor(s) with a copy of this EUA and communicate to
authorized distributor(s) any subsequent revisions that might be made to this EUA and its
authorized accompanying materials, including the authorized labeling.
K. You must make the authorized “Lucira by Pfizer COVID-19 & Flu Home Test
Instructions for Use” and the Fact Sheet for Healthcare Professionals electronically
available on your website. Additionally, you must provide the opportunity to request a
copy of the “Lucira by Pfizer COVID-19 & Flu Home Test Instructions for Use” and the
Fact Sheet for Healthcare Professionals in paper form, and after such request, promptly
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provide the requested labeling at no additional cost.
L. You may request changes to this EUA for your product, including to the Scope of
Authorization (Section II in this letter) or to the authorized labeling, including requests to
make available additional authorized labeling specific to an authorized distributor. Such
additional labeling may use another name for the product but otherwise must be
consistent with the authorized labeling, and not exceed the terms of authorization of this
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letter. Any request for changes to this EUA should be submitted to
DMD/OHT7/OPEQ/CDRH and require appropriate authorization from FDA prior to
implementation.
M. You may request new box labels to allow additional test kits numbers/options for your
product. Such additional labeling requests to this EUA should be submitted to and require
concurrence of DMD/OHT7/OPEQ/CDRH prior to implementation.
N. You must have lot release procedures and the lot release procedures, including the study
R design and statistical power, must ensure that the tests released for distribution have the
clinical and analytical performance claimed in the authorized labeling.
O. If requested by FDA, you must submit lot release procedures to FDA, including sampling
protocols, testing protocols, and acceptance criteria, that you use to release lots of your
product for distribution in the U.S. If such lot release procedures are requested by FDA,
you must provide them within 48 hours of the request.
Page 8 –Elizabeth Mauro, Pfizer Inc.
P. You must evaluate the analytical limit of detection and assess traceability 11 of your
product with any FDA-recommended reference material(s) if requested by FDA. After
submission to and concurrence with the data by FDA, you must update your labeling to
reflect the additional testing if requested by FDA. Such labeling updates will be made
in consultation with, and require concurrence of, DMD/OHT7/OPEQ/CDRH.
Q. You must further evaluate the clinical performance of your product in an FDA agreed
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upon post authorization clinical evaluation study and timeframe specific for Influenza B.
After submission to, and concurrence with, the data by FDA, you must update
authorized labeling to reflect the additional testing. Such labeling updates will be made
in consultation with, and require concurrence of, DMD/OHT7/OPEQ/CDRH.
R. You must complete the agreed upon real-time stability study for your product and notify
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DMD/OHT7/OPEQ/CDRH of the testing results as they become available until
completion of the study. After submission of the study data, and review and concurrence
with the data by FDA, you must update your product labeling accordingly. Such labeling
updates must be made in consultation with, and require concurrence of,
DMD/OHT7/OPEQ/CDRH.
S. You must maintain a quality system that is appropriate for your product’s design and
manufacture, and that meets the requirements of the 2016 edition of ISO 13485. If
requested by FDA, you must submit associated documents or records related to your
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quality system for FDA review within 48 hours of the request.
T. You must evaluate the impact of SARS-CoV-2 viral mutations and all other target
analytes on your product’s performance. Such evaluations must occur on an ongoing
basis and must include any additional data analysis that is requested by FDA in response
to any performance concerns you or FDA identify during routine evaluation.
Additionally, if requested by FDA, you must submit records of these evaluations for FDA
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review within 48 hours of the request. If your evaluation identifies viral mutations that
affect the stated expected performance of your device, you must notify FDA immediately
(via email: CDRH-EUA-Reporting@fda.hhs.gov).
U. If requested by FDA, you must update your labeling within 7 calendar days to include
any additional labeling risk mitigations identified by FDA regarding the impact of viral
mutations on test performance. Such updates will be made in consultation with, and
require concurrence of, DMD/OHT7/OPEQ/CDRH.
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Conditions Related to Printed Materials, Advertising and Promotion
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V. All descriptive printed matter, advertising and promotional materials relating to the use
of your product shall be consistent with the authorized labeling, as well as the terms set
forth in this EUA and meet the requirements set forth in section 502(a), (q)(1), and (r) of
the Act, as applicable, and FDA implementing regulations.
Traceability refers to tracing analytical sensitivity/reactivity back to an FDA-recommended reference material.
Page 9 –Elizabeth Mauro, Pfizer Inc.
W. No descriptive printed matter, advertising or promotional materials relating to the use of
your product may represent or suggest that this test is safe or effective for the detection of
SARS-CoV-2.
X. All descriptive printed matter, advertising and promotional materials relating to the use
of your product shall clearly and conspicuously state that:
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· This product has not been FDA cleared or approved, but has been authorized for
emergency use by FDA under an EUA;
· This product has been authorized only for the detection and differentiation of
nucleic acid from SARS-CoV-2, influenza A, and influenza B, not for any other
viruses or pathogens; and
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· The emergency use of this product is only authorized for the duration of the
declaration that circumstances exist justifying the authorization of emergency use
of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section
564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-
3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
The emergency use of your product as described in this letter of authorization must comply
with the conditions and all other terms of this authorization.
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V. Duration of Authorization
This EUA will be effective until the declaration that circumstances exist justifying the
authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of
COVID-19 is terminated under Section 564(b)(2) of the Act or the EUA is revoked under
Section 564(g) of the Act.
O Sincerely,
____________________________
Jeffrey E. Shuren, M.D., J.D.
Director
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Enclosure
Center for Devices and Radiological Health
Food and Drug Administration
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