Notice2024-16345
Revocation of Authorization of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 25, 2024
Effective
May 22, 2024
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 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.
Full Text
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<title>Federal Register, Volume 89 Issue 143 (Thursday, July 25, 2024)</title>
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[Federal Register Volume 89, Number 143 (Thursday, July 25, 2024)]
[Notices]
[Pages 60435-60436]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>.
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.
[[Page 60436]]
[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
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