Notice2022-11122
Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability
Primary source
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Published
May 24, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 100 (Tuesday, May 24, 2022)</title>
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[Federal Register Volume 87, Number 100 (Tuesday, May 24, 2022)]
[Notices]
[Pages 31565-31567]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>.
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.
BILLING CODE 4164-01-P
[GRAPHIC] [TIFF OMITTED] TN24MY22.001
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Dated: May 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-11122 Filed 5-23-22; 8:45 am]
BILLING CODE 4164-01-C
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