Notice2024-10910
Revocation of Two Authorizations 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
May 17, 2024
Effective
March 27, 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 Authorizations (EUAs) (the Authorizations) issued to Bio-Rad Laboratories Inc., for the Bio-Rad SARS-CoV-2 ddPCR Kit, and Fast Track Diagnostics Luxembourg S.[aacute].r.l. (A Siemens Healthineers Company), for the FTD SARS-CoV- 2. FDA revoked the Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holders. 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 89 Issue 97 (Friday, May 17, 2024)</title>
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[Federal Register Volume 89, Number 97 (Friday, May 17, 2024)]
[Notices]
[Pages 43411-43413]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-10910]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0150]
Revocation of Two Authorizations 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 Authorizations (EUAs) (the
Authorizations) issued to Bio-Rad Laboratories Inc., for the Bio-Rad
SARS-CoV-2 ddPCR Kit, and Fast Track Diagnostics Luxembourg
S.[aacute].r.l. (A Siemens Healthineers Company), for the FTD SARS-CoV-
2. FDA revoked the Authorizations under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) as requested by the Authorization holders. The
revocations, which include an explanation of the reasons for each
revocation, are reprinted at the end of this document.
DATES: The revocation of the Authorization for the Bio-Rad Laboratories
Inc.'s Bio-Rad SARS-CoV-2 ddPCR Kit is effective as of March 27, 2024.
The revocation of the Authorization for the Fast Track Diagnostics
Luxembourg S.[aacute].r.l.'s (A Siemens Healthineers Company), FTD
SARS-CoV-2 is effective as of April 18, 2024.
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 May 1, 2020, FDA
issued the Authorization to Bio-Rad Laboratories Inc., for the Bio-Rad
SARS-CoV-2 ddPCR Kit, subject to the terms of the Authorization. Notice
of the issuance of this Authorization was published in the Federal
Register on July 14, 2020 (85 FR 42409), as required by section
564(h)(1) of the FD&C Act.
On May 5, 2020, FDA issued the Authorization to Fast Track
Diagnostics Luxembourg S.[aacute].r.l. (a Siemens Healthineers Company)
for the FTD SARS-CoV-2, subject to the terms of the Authorization.
Notice of the issuance of this Authorization was published in the
Federal Register on July 14, 2020 (85 FR 42409), 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. Authorizations Revocation Requests
In a request received by FDA on March 16, 2024, Bio-Rad
Laboratories Inc., requested the revocation of, and on March 27, 2024,
FDA revoked, the Authorization for the Bio-Rad Laboratories Inc.'s Bio-
Rad SARS-CoV-2 ddPCR Kit. Because Bio-Rad Laboratories Inc., notified
FDA that they ceased United States distribution of the Bio-Rad SARS-
CoV-2 ddPCR Kit and requested FDA revoke Bio-Rad Laboratories Inc.'s
Bio-Rad SARS-CoV-2 ddPCR Kit, 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 April 11, 2024, Fast Track
Diagnostics Luxembourg S.[aacute].r.l. (a Siemens Healthineers
Company), requested the deregister of, and on April 18, 2024, FDA
revoked, the Authorization for Fast Track Diagnostics Luxembourg
S.[aacute].r.l.'s FTD SARS-CoV-2. Because Fast Track Diagnostics
Luxembourg S.[aacute].r.l. notified FDA that they have ceased United
States distribution of the FTD SARS-CoV-2 and requested FDA deregister
the Fast Track Diagnostics Luxembourg S.[aacute].r.l.'s FTD SARS-CoV-2,
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 Bio-Rad Laboratories Inc.'s Bio-Rad SARS-CoV-2
ddPCR Kit, and Fast Track Diagnostics Luxembourg S.[aacute].r.l.'s (a
Siemens Healthineers Company) FTD SARS-CoV-2. The revocations in their
entirety follow and provide an explanation of the reasons for
revocation, as required by section 564(h)(1) of the FD&C Act.
BILLING CODE 4164-01-P
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Dated: May 14, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-10910 Filed 5-16-24; 8:45 am]
BILLING CODE 4164-01-C
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