Notices. Notice
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/register/2022/09/09/2022-19491A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4164-01-P 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 Devices 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 Becton, Dickinson and Company
(BD)for the BD SARS-CoV-2/Flu for BD MAX System, and Talis Biomedical Corporation (Talis) for the Talis One COVID-19 Test System. FDA revoked these Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document. DATES: The Authorization for the BD SARS-CoV-2/Flu for BD MAX System is revoked as of August 1, 2022. The Authorization for the Talis One COVID-19 Test System is revoked as of August 23, 2022. ADDRESSES: Submit written requests for a single copy of the revocations to the Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, 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: Jennifer J. Ross, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-0002, 301-796-8510 (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, nuclear, and radiological 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 February 10, 2021, FDA issued an EUA to BD for the BD SARS-CoV-2/Flu for BD MAX System, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the **Federal Register** on April 23, 2021 (86 FR 21749), as required by section 564(h)(1) of the FD&C Act. On November 5, 2021, FDA issued an EUA to Talis for the Talis One COVID-19 Test System, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the **Federal Register** on March 22, 2022 (87 FR 16196), 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. EUA Revocation Requests In a request received by FDA on July 26, 2022, BD requested withdrawal of, and effective August 1, 2022, FDA revoked, the Authorization for the BD SARS-CoV-2/Flu for BD MAX System. Because BD notified FDA that BD has discontinued the sale of the BD SARS-CoV-2/Flu for BD MAX System and requested FDA to withdraw the authorization of the BD SARS-CoV-2/Flu for BD MAX System, 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 August 12, 2022, Talis requested revocation of, and on August 23, 2022, FDA revoked, the Authorization for the Talis One COVID-19 Test System. Because Talis notified FDA that Talis has not commercially distributed the authorized product in the United States and requested FDA revoke the authorization of the Talis One COVID-19 Test System, 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 BD for the BD SARS-CoV-2/Flu for BD MAX System and of Talis for the Talis One COVID-19 Test System. The revocations in their entirety follow and provide an explanation of the reasons for each revocation, as required by section 564(h)(1) of the FD&C Act. BILLING CODE 4164-01-P EN09SE22.044 EN09SE22.045 Dated: September 2, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022-19491 Filed 9-8-22; 8:45 am]
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- Pub. L. 108-276
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