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Food and Drug Administration, HHS.
Notice.
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.á.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.
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.á.r.l.'s (A Siemens Healthineers Company), FTD SARS-CoV-2 is effective as of April 18, 2024.
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.
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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).
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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.á.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 circ*mstances 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.á.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.á.r.l.'s FTD SARS-CoV-2. Because Fast Track Diagnostics Luxembourg S.á.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.á.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.á.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.
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Dated: May 14, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
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[FR Doc. 2024-10910 Filed 5-16-24; 8:45 am]
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