Notice2022-18529
Authorization and Revocations of Emergency Use of Certain In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
Primary source
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Published
August 26, 2022
Effective
May 28, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing the issuance of one, and revocation of three, Emergency Use Authorizations (EUAs) (the Authorizations) issued to STS Lab Holdco (a subsidiary of Amazon.com Services LLC) ("STS"). FDA issued one Authorization under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as requested by STS, for the Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2. The Authorization contains, among other things, conditions on the emergency use of the authorized product. The Authorization follows the February 4, 2020, determination by the Secretary of Health and Human Services (HHS) that there is a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad, and that involves the virus that causes COVID-19, and the subsequent declaration on February 4, 2020, 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 the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is listed in this document, and further information can be accessed on FDA's website from the links indicated. FDA is also announcing the subsequent revocation of the Authorization issued to STS for the Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2. In addition, FDA is announcing the revocation of the Authorizations issued to STS for the Amazon Multi- Target SARS-CoV-2 Real-Time RT-PCR DTC Test and Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR Test. FDA issued and revoked the Authorizations under the FD&C Act. The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document.
Full Text
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<title>Federal Register, Volume 87 Issue 165 (Friday, August 26, 2022)</title>
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[Federal Register Volume 87, Number 165 (Friday, August 26, 2022)]
[Notices]
[Pages 52580-52584]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-18529]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0412]
Authorization and Revocations of Emergency Use of Certain In
Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of one, and revocation of three, Emergency Use Authorizations
(EUAs) (the Authorizations) issued to STS Lab Holdco (a subsidiary of
<a href="http://Amazon.com">Amazon.com</a> Services LLC) (``STS''). FDA issued one Authorization under
the Federal Food, Drug, and Cosmetic Act (FD&C Act), as requested by
STS, for the Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2.
The Authorization contains, among other things, conditions on the
emergency use of the authorized product. The Authorization follows the
February 4, 2020, determination by the Secretary of Health and Human
Services (HHS) that there is a public health emergency that has a
significant potential to affect national security or the health and
security of U.S. citizens living abroad, and that involves the virus
that causes COVID-19, and the subsequent declaration on February 4,
2020, 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 the terms of any
authorization issued under the FD&C Act. The Authorization, which
includes an explanation of the reasons for issuance, is listed in this
document, and further information can be accessed on FDA's website from
the links indicated. FDA is also announcing the subsequent revocation
of the Authorization issued to STS for the Amazon Real-Time RT-PCR DTC
Test for Detecting SARS-CoV-2. In addition, FDA is announcing the
revocation of the Authorizations issued to STS for the Amazon Multi-
Target SARS-CoV-2 Real-Time RT-PCR DTC Test and Amazon Multi-Target
SARS-CoV-2 Real-Time RT-PCR Test. FDA issued and revoked the
Authorizations under the FD&C Act. The revocations, which include an
explanation of the reasons for each revocation, are reprinted in this
document.
DATES: The Authorization for the Amazon Real-Time RT-PCR DTC Test for
Detecting SARS-CoV-2 was effective May 28, 2021. The revocations for
the Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2, Amazon
Multi-Target SARS-CoV-2 Real-Time RT-PCR DTC Test, and Amazon Multi-
Target SARS-CoV-2 Real-Time RT-PCR Test are effective as of July 19,
2022.
ADDRESSES: Submit written requests for a single copy of the
Authorization or the revocations to the Office of Counterterrorism and
Emerging Threats, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4338, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request or include a Fax number to which the documents may be sent. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
documents.
FOR FURTHER INFORMATION CONTACT: Jennifer J. Ross, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002, 301-796-8510 (this is not a toll-free number).
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5)
allows FDA to strengthen the public health protections against
biological, chemical, nuclear, and radiological agents. With this EUA
authority, FDA can help ensure that medical countermeasures may be used
in emergencies to diagnose, treat, or prevent serious or life-
threatening diseases or conditions caused by biological, chemical,
nuclear, or radiological agents when there are no adequate, approved,
and available alternatives.
II. Criteria for EUA Authorization
Section 564(b)(1) of the FD&C Act provides that, before an EUA may
be issued, the Secretary of HHS must declare that circumstances exist
justifying the authorization based on one of the following grounds: (1)
a determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a biological,
chemical, radiological, or nuclear agent or agents; (2) a determination
by the Secretary of Defense that there is a military emergency, or a
significant potential for a military emergency, involving a heightened
risk to U.S. military forces, including personnel operating under the
authority of title 10 or title 50 of the U.S. Code, of attack with (A)
a biological, chemical, radiological, or nuclear agent or agents; or
(B) an agent or agents that may cause, or are otherwise associated
with, an imminently life-threatening and specific risk to U.S. military
forces; \1\ (3) a determination by the Secretary of HHS that there is a
public health emergency, or a significant potential for a public health
emergency, that affects, or has a significant potential to affect,
national security or the health and security of U.S. citizens living
abroad, and that involves a biological, chemical, radiological, or
nuclear agent or agents, or a disease or condition that may be
attributable to such agent or agents; or (4) the identification of a
material threat by the Secretary of Homeland Security pursuant to
section 319F-2 of the Public Health Service (PHS) Act (42 U.S.C. 247d-
6b) sufficient to affect national security or the health and security
of U.S. citizens living abroad.
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\1\ In the case of a determination by the Secretary of Defense,
the Secretary of HHS shall determine within 45 calendar days of such
determination, whether to make a declaration under section 564(b)(1)
of the FD&C Act, and, if appropriate, shall promptly make such a
declaration.
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Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the reasons
for the action. Under section 564(h)(1) of the FD&C Act, revisions to
an authorization shall be made available on the FDA website. Section
564 of the FD&C Act permits FDA to authorize the introduction into
interstate commerce of a drug, device, or biological product intended
for use when the Secretary of HHS has declared that circumstances exist
justifying the authorization of emergency use. Products appropriate for
emergency use may include products and uses that are not approved,
cleared, or licensed under section 505, 510(k), 512, or 515 of the FD&C
Act (21 U.S.C. 355, 360(k), 360b, or 360e) or section 351 of the PHS
Act (42 U.S.C. 262), or
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conditionally approved under section 571 of the FD&C Act (21 U.S.C.
360ccc). FDA may issue an EUA only if, after consultation with the HHS
Assistant Secretary for Preparedness and Response, the Director of the
National Institutes of Health, and the Director of the Centers for
Disease Control and Prevention (to the extent feasible and appropriate
given the applicable circumstances), FDA \2\ concludes: (1) that an
agent referred to in a declaration of emergency or threat can cause a
serious or life-threatening disease or condition; (2) that, based on
the totality of scientific evidence available to FDA, including data
from adequate and well-controlled clinical trials, if available, it is
reasonable to believe that (A) the product may be effective in
diagnosing, treating, or preventing (i) such disease or condition; or
(ii) a serious or life-threatening disease or condition caused by a
product authorized under section 564, approved or cleared under the
FD&C Act, or licensed under section 351 of the PHS Act, for diagnosing,
treating, or preventing such a disease or condition caused by such an
agent; and (B) the known and potential benefits of the product, when
used to diagnose, prevent, or treat such disease or condition, outweigh
the known and potential risks of the product, taking into consideration
the material threat posed by the agent or agents identified in a
declaration under section 564(b)(1)(D) of the FD&C Act, if applicable;
(3) that there is no adequate, approved, and available alternative to
the product for diagnosing, preventing, or treating such disease or
condition; (4) in the case of a determination described in section
564(b)(1)(B)(ii), that the request for emergency use is made by the
Secretary of Defense; and (5) that such other criteria as may be
prescribed by regulation are satisfied. No other criteria for issuance
have been prescribed by regulation under section 564(c)(4) of the FD&C
Act
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\2\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
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III. Authorizations
Having concluded that the criteria for the issuance of the
Authorization under section 564(c) of the FD&C Act are met, on May 28,
2021, FDA issued an EUA to STS for the Amazon Real-Time RT-PCR DTC Test
for Detecting SARS-CoV-2, subject to the terms of the Authorization.
Notice of the issuance of this Authorization is provided, as required
by section 564(h)(1) of the FD&C Act.\3\
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\3\ An explanation of the reasons for issuance of the
Authorization is provided, as required by section 564(h)(1) of the
FD&C Act. As set forth in the EUA for the Amazon Real-Time RT-PCR
DTC Test for Detecting SARS-CoV-2, FDA has concluded that (1) 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 that the Amazon Real-Time RT-PCR
DTC Test for Detecting SARS-CoV-2 may be effective in diagnosing
COVID-19, and that the known and potential benefits of the Amazon
Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2 when used for
diagnosing COVID-19, outweigh the known and potential risks of the
Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2; and (3)
there is no adequate, approved, and available alternative to the
emergency use of Amazon Real-Time RT-PCR DTC Test for Detecting
SARS-CoV-2.
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On August 11, 2021, FDA issued EUAs to STS Lab Holdco for the
Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR DTC Test and Amazon
Multi-Target SARS-CoV-2 Real-Time RT-PCR Test, subject to the terms of
the respective Authorizations. Notice of the issuance of these
Authorizations was published in the Federal Register on October 28,
2021 (86 FR 59738), as required by section 564(h)(1) of the FD&C Act.
Subsequent updates to the Authorizations were made available on FDA's
website.
The authorization of a device for emergency use under section 564
of the FD&C Act may, pursuant to section 564(g)(2) of the FD&C Act, be
revoked when the criteria under section 564(c) of the FD&C Act for
issuance of such authorization are no longer met (section 564(g)(2)(B)
of the FD&C Act), or other circumstances make such revocation
appropriate to protect the public health or safety (section
564(g)(2)(C) of the FD&C Act).
IV. EUA Revocation Requests
On July 11, 2022, STS Lab Holdco requested revocation of, and on
July 19, 2022, FDA revoked, the Authorizations for the Amazon Real-Time
RT-PCR DTC Test for Detecting SARS-CoV-2, Amazon Multi-Target SARS-CoV-
2 Real-Time RT-PCR DTC Test, and Amazon Multi-Target SARS-CoV-2 Real-
Time RT-PCR Test. Because STS Lab Holdco has notified FDA that there is
no viable (non-expired) Amazon Real-Time RT-PCR DTC Test for Detecting
SARS-CoV-2, Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR DTC Test,
or Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR Test remaining in
distribution in the United States and requested FDA revoke the
Authorizations for these devices, FDA has determined that it is
appropriate to protect the public health or safety to revoke these
Authorizations.
V. Electronic Access
An electronic version of this document and the full text of the
revocations are available on the internet at <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>. The full text of the Authorization, including any
revisions, and of the revocations and can be accessed from the FDA web
page available at: <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization-archived-information">https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization-archived-information</a>.
VI. The Revocations
Having concluded that the criteria for revocation of the
Authorizations under section 564(g)(2)(C) of the FD&C Act are met, FDA
has revoked the EUAs for STS Lab Holdco's Amazon Real-Time RT-PCR DTC
Test for Detecting SARS-CoV-2, Amazon Multi-Target SARS-CoV-2 Real-Time
RT-PCR DTC Test, and Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR
Test. The revocations in their entirety follow and provide an
explanation of the reasons for each revocation, as required by section
564(h)(1) of the FD&C Act.
BILLING CODE 4164-01-P
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[GRAPHIC] [TIFF OMITTED] TN26AU22.007
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[GRAPHIC] [TIFF OMITTED] TN26AU22.008
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[GRAPHIC] [TIFF OMITTED] TN26AU22.009
Dated: August 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18529 Filed 8-25-22; 8:45 am]
BILLING CODE 4164-01-C
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