Document ID: FDA-2021-N-0973-0006
Agency: fda
Document Type: Notice
Title: Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID–19; Availability
Posted Date: 2023-05-10T04:00Z

[Federal Register Volume 88, Number 90 (Wednesday, May 10, 2023)]
[Notices]
[Pages 30135-30139]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov/.

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.
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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]
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