[Federal Register Volume 89, Number 143 (Thursday, July 25, 2024)]
[Notices]
[Pages 60435-60436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16345]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0150]


Revocation of Authorization of Emergency Use of In Vitro 
Diagnostic Device 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 Authorization (EUA) (the Authorization) 
issued to Mesa Biotech Inc., (a legal entity of Thermo Fisher 
Scientific), for the Accula SARS-CoV-2 Test. FDA revoked the 
Authorization under the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
as requested by the Authorization holder. The revocation, which 
includes an explanation of the reasons for revocation, is reprinted at 
the end of this document.

DATES: The revocation of the Authorization for the Mesa Biotech Inc.'s 
Accula SARS-CoV-2 Test is effective as of May 22, 2024.

ADDRESSES: Submit written requests for a single copy of the revocation 
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 revocation may be sent. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the revocation.

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 March 23, 2020, FDA issued the Authorization to Mesa Biotech 
Inc. (a legal entity of Thermo Fisher Scientific), for the Accula SARS-
CoV-2 Test, subject to the terms of the Authorization. Notice of the 
issuance of this Authorization was published in the Federal Register on 
June 5, 2020 (85 FR 34638), as required by section 564(h)(1) of the 
FD&C Act.
    Subsequent updates to the Authorization 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 Request

    In a request received by FDA on May 15, 2024, Mesa Biotech Inc. (a 
legal entity of Thermo Fisher Scientific), made by Thermo Fisher 
Scientific, Inc. on behalf of Mesa Biotech Inc., requested the 
revocation of, and on May 22, 2024, FDA revoked, the Authorization for 
the Mesa Biotech Inc.'s Accula SARS-CoV-2 Test. Because Mesa Biotech 
Inc., notified FDA that they discontinued the commercialization of the 
Accula SARS-CoV-2 Test and requested FDA revoke Mesa Biotech Inc.'s 
Accula SARS-CoV-2 Test, 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 Revocation

    Having concluded that the criteria for revocation of the 
Authorization under section 564(g)(2)(C) of the FD&C Act are met, FDA 
has revoked the EUA of Mesa Biotech Inc.'s Accula SARS-CoV-2 Test. The 
revocation in its entirety follows and provide an explanation of the 
reasons for revocation, as required by section 564(h)(1) of the FD&C 
Act.

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[GRAPHIC] [TIFF OMITTED] TN25JY24.001


    Dated: July 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-16345 Filed 7-24-24; 8:45 am]
BILLING CODE 4161-01-P