Document ID: FDA-2021-N-0973-0003
Agency: fda
Document Type: Notice
Title: Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID–19; Availability
Posted Date: 2022-01-13T05:00Z

[Federal Register Volume 87, Number 9 (Thursday, January 13, 2022)]
[Notices]
[Pages 2163-2167]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00521]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Revocation of Three 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.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
revocation of the Emergency Use Authorizations (EUAs) (the 
Authorizations) issued to Becton, Dickinson & Company (BD) for the 
BioGX SARS-CoV-2 Reagents for BD MAX System, Boston Medical Center for 
the BMC-CReM COVID-19 Test, and Akron Children's Hospital for the Akron 
Children's Hospital SARS-CoV-2 Assay. FDA revoked these Authorizations 
on December 8, 2021, under the Federal Food, Drug, and

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Cosmetic Act (FD&C Act). The revocations, which include an explanation 
of the reasons for each revocation, are reprinted in this document.

DATES: The Authorizations for the BioGX SARS-CoV-2 Reagents for BD MAX 
System, BMC-CReM COVID-19 Test, and Akron Children's Hospital SARS-CoV-
2 Assay are revoked as of December 8, 2021.

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

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 April 2, 2020, FDA issued an 
EUA to BD for the BioGX SARS-CoV-2 Reagents for BD MAX System, subject 
to the terms of the Authorization. Notice of the issuance of this 
Authorization was published in the Federal Register on June 5, 2020 (85 
FR 34638), as required by section 564(h)(1) of the FD&C Act. On July 
10, 2020, FDA issued an EUA to Boston Medical Center for the BMC-CReM 
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 September 29, 2020, FDA issued an EUA to Akron 
Children's Hospital for the Akron Children's Hospital SARS-CoV-2 Assay, 
subject to the terms of the Authorization. Notice of the issuance of 
this Authorization was published in the Federal Register on April 23, 
2021 (86 FR 21749), 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. EUA Revocation Requests

    On December 3, 2021, FDA received a request from BD for the 
revocation of, and on December 8, 2021, FDA revoked, the Authorization 
for the BioGX SARS-CoV-2 Reagents for BD MAX System. Because BD 
notified FDA that BD discontinued the sale of the authorized product 
and requested FDA revoke the Authorization, FDA has determined that it 
is appropriate to protect the public health or safety to revoke this 
Authorization. On October 4, 2021 (and reconfirmed December 6, 2021), 
FDA received a request from Boston Medical Center for the revocation 
of, and on December 8, 2021, FDA revoked, the Authorization for the 
BMC-CReM COVID-19 Test. Because Boston Medical Center notified FDA that 
the BMC-CReM COVID-19 Test is no longer performed pursuant to the EUA 
and requested FDA withdraw the Authorization, FDA has determined that 
it is appropriate to protect the public health or safety to revoke this 
Authorization. On December 3, 2021, FDA received a request from Akron 
Children's Hospital for the revocation of, and on December 8, 2021, FDA 
revoked, the Authorization for the Akron Children's Hospital SARS-CoV-2 
Assay. Because Akron Children's Hospital notified FDA that it stopped 
performing the Akron Children's Hospital SARS-CoV-2 Assay and requested 
that 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 
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 for BD's BioGX SARS-CoV-2 Reagents for BD MAX 
System, Boston Medical Center's BMC-CReM COVID-19 Test, and Akron 
Children's Hospital's Akron Children's Hospital SARS-CoV-2 Assay. The 
revocations in their entirety follow and provide an explanation of the 
reasons for each revocation, as required by section 564(h)(1) of the 
FD&C Act.
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    Dated: January 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-00521 Filed 1-12-22; 8:45 am]
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