Notice2023-09879
Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
Primary source
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Published
May 10, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Thermo Fisher Scientific Inc., for the OmniPATH COVID-19 Total Antibody ELISA Test; Detect, Inc., for the Detect Covid-19 Test; and Cepheid, for the Xpert Xpress SARS-CoV-2/Flu/ RSV. FDA revoked these Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by each Authorization holder. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document.
Full Text
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<title>Federal Register, Volume 88 Issue 90 (Wednesday, May 10, 2023)</title>
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[Federal Register Volume 88, Number 90 (Wednesday, May 10, 2023)]
[Notices]
[Pages 30135-30139]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-09879]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0973]
Revocation of Three Authorizations of Emergency Use of 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
revocation of the Emergency Use Authorizations (EUAs) (the
Authorizations) issued to Thermo Fisher Scientific Inc., for the
OmniPATH COVID-19 Total Antibody ELISA Test; Detect, Inc., for the
Detect Covid-19 Test; and Cepheid, for the Xpert Xpress SARS-CoV-2/Flu/
RSV. FDA revoked these Authorizations under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) as requested by each Authorization holder. The
revocations, which include an explanation of the reasons for each
revocation, are reprinted at the end of this document.
DATES: The Authorization for the Thermo Fisher Scientific Inc.'s
OmniPATH COVID-19 Total Antibody ELISA Test is revoked as of April 13,
2023. The Authorization for the Detect, Inc.'s Detect Covid-19 Test is
revoked as of April 14, 2023. The Authorization for the Cepheid's Xpert
Xpress SARS-CoV-2/Flu/RSV is revoked as of April 17, 2023.
ADDRESSES: Submit written requests for a single copy of the revocations
to the Office of Policy, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
5431, 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 revocations may be sent. See the SUPPLEMENTARY
INFORMATION section for electronic access to the revocations.
FOR FURTHER INFORMATION CONTACT: Kim Sapsford-Medintz, Office of
Product Evaluation and Quality, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 3216, Silver Spring, MD 20993-0002, 301-796-0311 (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, radiological, or nuclear agent or agents. Among
other things, section 564 of the FD&C Act allows FDA to authorize the
use of an unapproved medical product or an unapproved use of an
approved medical product in certain situations. On October 2, 2020, FDA
issued the Authorization to Thermo Fisher Scientific Inc., for the
OmniPATH COVID-19 Total Antibody ELISA Test, subject to the terms of
the Authorization. Notice of the issuance of this Authorization was
published in the Federal Register on April 23, 2021 (86 FR 21749), as
required by section 564(h)(1) of the FD&C Act. On October 28, 2021, FDA
issued the Authorization to Detect, Inc., for the Detect Covid-19 Test,
subject to the terms of the Authorization. Notice of the issuance of
this Authorization was published in the Federal Register on March 22,
2022 (87 FR 16198), as required by section 564(h)(1) of the FD&C Act.
On September 24, 2020, FDA issued the Authorization to Cepheid, for the
Xpert Xpress SARS-CoV-2/Flu/RSV, subject to the terms of the
Authorization. Notice of the issuance of this Authorization was
published in the Federal Register on April 23, 2021 (86 FR 21751), 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).
II. Authorization Revocation Requests
In a request received by FDA on April 10, 2023, Thermo Fisher
Scientific Inc., requested the withdrawal of, and on April 13, 2023,
FDA revoked, the Authorization for the Thermo Fisher Scientific Inc.'s
OmniPATH COVID-19
[[Page 30136]]
Total Antibody ELISA Test. Because Thermo Fisher Scientific Inc.,
notified FDA that it is no longer manufacturing or producing the
OmniPATH COVID-19 Total Antibody ELISA Test and requested FDA withdraw
the Thermo Fisher Scientific Inc.'s, OmniPATH COVID-19 Total Antibody
ELISA Test, FDA has determined that it is appropriate to protect the
public health or safety to revoke this Authorization.
In a request received by FDA on March 16, 2023, Detect, Inc.,
requested revocation of, and on April 14, 2023, FDA revoked, the
Authorization for the Detect, Inc.'s Detect Covid-19 Test. Because
Detect, Inc., indicated to FDA that as of February 1, 2023, there are
no viable/nonexpired Detect Covid-19 Tests in distribution in the
United States and requested FDA revoke the Authorization for the Detect
Covid-19 Test, FDA has determined that it is appropriate to protect the
public health or safety to revoke this Authorization.
In a request received by FDA on March 7, 2023, Cepheid, requested
revocation of, and on April 17, 2023, FDA revoked, the Authorization
for the Cepheid's Xpert Xpress SARS-CoV-2/Flu/RSV. Because Cepheid,
indicated to FDA that they have stopped sales of the authorized product
and requested FDA revoke the Authorization for the Cepheid's Xpert
Xpress SARS-CoV-2/Flu/RSV, FDA has determined that it is appropriate to
protect the public health or safety to revoke this Authorization.
III. 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>.
IV. 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 EUA of Thermo Fisher Scientific Inc.'s OmniPATH COVID-
19 Total Antibody ELISA Test; Detect, Inc's Detect Covid-19 Test; and
of Cepheid's Xpert Xpress SARS-CoV-2/Flu/RSV. 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 4161-01-P
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Dated: May 4, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09879 Filed 5-9-23; 8:45 am]
BILLING CODE 4161-01-C
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