89 FR 224 pgs. 91760-91763 - Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
Type: NOTICEVolume: 89Number: 224Pages: 91760 - 91763
Pages: 91760, 91761, 91762, 91763Docket number: [Docket No. FDA-2022-N-0150]
FR document: [FR Doc. 2024-27094 Filed 11-19-24; 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 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 Cue Health, Inc., for the Cue COVID-19 Test, and Cue COVID-19 Test for Home and Over The Counter (OTC) Use. FDA revoked the Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. 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 Authorizations for the Cue Health, Inc.'s Cue COVID-19 Test, and Cue COVID-19 Test for Home and Over The Counter (OTC) Use are effective as of October 9, 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).
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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 June 10, 2020, FDA issued the Authorization to Cue Health, Inc., for the Cue COVID-19 Test, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on November 20, 2020 (85 FR 74346), as required by section 564(h)(1) of the FD&C Act.
On March 5, 2021, FDA issued the Authorization to Cue Health, Inc., for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on July 23, 2021 (86 FR 39040), 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 September 9, 2024, Cue Health, Inc., requested the revocation of, and on October 9, 2024, FDA revoked, the Authorization for the Cue Health, Inc.'s Cue COVID-19 Test. Because Cue Health, Inc., notified FDA that they ceased manufacturing, shipping, and distributing the Cue COVID-19 Test and requested FDA revoke the Cue COVID-19 Test, 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 September 9, 2024, Cue Health, Inc., requested the revocation of, and on October 9, 2024, FDA revoked, the Authorization for Cue Health, Inc.'s Cue COVID-19 Test for Home and Over The Counter (OTC) Use. Because Cue Health, Inc., notified FDA that they have ceased manufacturing, shipping, and distributing the Cue COVID-19 Test for Home and Over The Counter (OTC) Use and requested FDA revoke the Cue COVID-19 Test for Home and Over The Counter (OTC) Use, 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 EUAs of Cue Health, Inc.'s Cue COVID-19 Test, and Cue COVID-19 Test for Home and Over The Counter (OTC) Use. 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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[Federal Register graphic "EN20NO24.071" is not available. Please view the graphic in the PDF version of this document.]
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[Federal Register graphic "EN20NO24.072" is not available. Please view the graphic in the PDF version of this document.]
Dated: November 14, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-27094 Filed 11-19-24; 8:45 am]
BILLING CODE 4164-01-C