90 FR 121 pgs. 27321-27323 - Revocation of Authorization of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability
Type: NOTICEVolume: 90Number: 121Pages: 27321 - 27323
Pages: 27321, 27322, 27323Docket number: [Docket No. FDA-2022-N-0150]
FR document: [FR Doc. 2025-11822 Filed 6-25-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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.
SUMMARY:
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Cepheid for the Xpert Xpress 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 reason for revocation, is reprinted at the end of this document.
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DATES:
The revocation of the Authorization for the Cepheid's Xpert Xpress SARS-CoV-2 test was effective as of May 28, 2025.
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 20, 2020, FDA issued the Authorization to Cepheid for the Xpert Xpress 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 21, 2025, Cepheid requested the revocation of, and on May 28, 2025, FDA revoked, the Authorization for the Cepheid's Xpert Xpress SARS-CoV-2 test. Cepheid notified FDA that all its U.S. customers transitioned to the Xpert Xpress SARS-CoV-2 plus product that was authorized under EUA220187, and requested FDA revoke the Cepheid's Xpert Xpress 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 revocation is available on the internet at https://www.regulations.gov/.
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 for Cepheid's Xpert Xpress SARS-CoV-2 test. The revocation in its entirety follows and provides an explanation of the reason for revocation, as required by section 564(h)(1) of the FD&C Act.
BILLING CODE 4164-01-P
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[Federal Register graphic "EN26JN25.006" is not available. Please view the graphic in the PDF version of this document.]
Dated: June 23, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-11822 Filed 6-25-25; 8:45 am]
BILLING CODE 4164-01-C