```

[Federal Register Volume 89, Number 224 (Wednesday, November 20, 2024)]
[Notices]
[Pages 91760-91763]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27094]

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

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).

[[Page 91761]]

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

[[Page 91762]]

[GRAPHIC] [TIFF OMITTED] TN20NO24.071

[[Page 91763]]

[GRAPHIC] [TIFF OMITTED] TN20NO24.072

    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
```