Notice2022-00521
Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
Primary source
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Published
January 13, 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 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 Cosmetic Act (FD&C Act). The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document.
Full Text
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<title>Federal Register, Volume 87 Issue 9 (Thursday, January 13, 2022)</title>
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[Federal Register Volume 87, Number 9 (Thursday, January 13, 2022)]
[Notices]
[Pages 2163-2167]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>.
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.
BILLING CODE 4164-01-P
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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]
BILLING CODE 4164-01-C
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