Document ID: FDA-2021-N-0973-0002
Agency: fda
Document Type: Notice
Title: Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID–19; Availability
Posted Date: 2021-10-28T04:00Z

[Federal Register Volume 86, Number 206 (Thursday, October 28, 2021)]
[Notices]
[Pages 59734-59735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23500]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0973]

Revocation of Authorization of Emergency Use of an In Vitro 
Diagnostic Device for Detection and/or Diagnosis of COVID-19; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
revocation of the Emergency Use Authorization (EUA) (the Authorization) 
issued to Life Technologies Corporation (a part of Thermo Fisher 
Scientific, Inc.) (Thermo Fisher) for the TaqPath COVID-19 MS2 Combo 
Kit 2.0. FDA revoked this Authorization on September 27, 2021, under 
the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocation, 
which includes an explanation of the reasons for revocation, is 
reprinted in this document.

DATES: The Authorization for the TaqPath COVID-19 MS2 Combo Kit 2.0 is 
revoked as of September 27, 2021.

ADDRESSES: Submit written requests for a single copy of the revocation 
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 revocation may be sent. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the revocation.

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, 240-402-8155 (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 August 2, 2021, FDA issued an 
EUA to Thermo Fisher for the TaqPath COVID-19 MS2 Combo Kit 2.0, 
subject to the terms of the Authorization. Notice of the issuance of 
the Authorization is published elsewhere in this issue of the Federal 
Register, as required by section 564(h)(1) of the FD&C Act. 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 Request

    On September 22, 2021, Thermo Fisher requested the revocation of, 
and on September 27, 2021, FDA revoked the Authorization for, the 
TaqPath COVID-19 MS2 Combo Kit 2.0. Because Thermo Fisher has notified 
FDA that it is longer commercially supporting the TaqPath COVID-19 MS2 
Combo Kit 2.0 and requested FDA revoke the Authorization, 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 are 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) of the FD&C Act are met, FDA has 
revoked the EUA for the TaqPath COVID-19 MS2 Combo Kit 2.0. The 
revocation in its entirety follows and provides an explanation of the 
reasons for revocation, as required by section 564(h)(1) of the FD&C 
Act.
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[[Page 59735]]

[GRAPHIC] [TIFF OMITTED] TN28OC21.002

    Dated: October 22, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23500 Filed 10-27-21; 8:45 am]
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