Document ID: FDA-2022-N-0150-0004
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: 2022-05-24T04:00Z

[Federal Register Volume 87, Number 100 (Tuesday, May 24, 2022)]
[Notices]
[Pages 31565-31567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-11122]

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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 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 Clinical Research Sequencing Platform (CRSP), LLC at the 
Broad Institute of MIT and Harvard (Broad Institute) for the CRSP SARS-
CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay. FDA 
revoked this Authorization 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 CRSP SARS-CoV-2 Real-time Reverse 
Transcriptase (RT)-PCR Diagnostic Assay is revoked as of May 5, 2022.

ADDRESSES: Submit a written request 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 July 8, 2020, FDA issued an 
EUA to the Broad Institute for the CRSP SARS-CoV-2 Real-time Reverse 
Transcriptase (RT)-PCR Diagnostic Assay, 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. 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. EUA Revocation Request

    In a request received by FDA on April 4, 2022, Broad Institute 
requested revocation of, and on May 5, 2022, FDA revoked, the 
Authorization for the CRSP SARS-CoV-2 Real-time Reverse Transcriptase 
(RT)-PCR Diagnostic Assay. Because the Broad Institute notified FDA 
that it has decided to discontinue use of the CRSP SARS-CoV-2 Real-time 
Reverse Transcriptase (RT)-PCR Diagnostic Assay and requested FDA 
revoke the EUA for the CRSP SARS-CoV-2 Real-time Reverse Transcriptase 
(RT)-PCR Diagnostic Assay, FDA has determined that it is

[[Page 31566]]

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 of Broad Institute for the CRSP SARS-CoV-2 Real-
time Reverse Transcriptase (RT)-PCR Diagnostic Assay. 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 31567]]

    Dated: May 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-11122 Filed 5-23-22; 8:45 am]
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