[Federal Register Volume 89, Number 97 (Friday, May 17, 2024)]
[Notices]
[Pages 43411-43413]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10910]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 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 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

[[Page 43412]]

[GRAPHIC] [TIFF OMITTED] TN17MY24.029


[[Page 43413]]


[GRAPHIC] [TIFF OMITTED] TN17MY24.030


    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