Notice2023-04845
Revocation of Two 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
March 9, 2023
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 Babson Diagnostics, Inc., for the Babson Diagnostics aC19G1, and Twist Bioscience Corporation for the SARS-CoV-2 NGS Assay. FDA revoked these Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by each Authorization holder. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document.
Full Text
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<title>Federal Register, Volume 88 Issue 46 (Thursday, March 9, 2023)</title>
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[Federal Register Volume 88, Number 46 (Thursday, March 9, 2023)]
[Notices]
[Pages 14622-14625]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-04845]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0150]
Revocation of Two 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 Babson Diagnostics, Inc., for the Babson
Diagnostics aC19G1, and Twist Bioscience Corporation for the SARS-CoV-2
NGS Assay. FDA revoked these Authorizations under the Federal Food,
Drug, and Cosmetic Act (FD&C Act) as requested by each Authorization
holder. The revocations, which include an explanation of the reasons
for each revocation, are reprinted at the end of this document.
DATES: The Authorization for the Babson Diagnostics aC19G1 is revoked
as of February 14, 2023. The Authorization for the SARS-CoV-2 NGS Assay
is revoked as of February 14, 2023.
ADDRESSES: Submit written requests for a single copy of the revocations
to the Office of Policy, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, Rm.
5431, 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: Kim Sapsford-Medintz, Office of
Product Evaluation and Quality, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg.
66, Rm. 3216, Silver Spring, MD 20993-0002, 301-796-0311 (this is not a
toll-free number).
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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 June 23, 2020, FDA issued the
Authorization to Babson Diagnostics, Inc., for the Babson Diagnostics
aC19G1, 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 March 23, 2021, FDA issued the Authorization to Twist
Bioscience Corporation for the SARS-CoV-2 NGS Assay, subject to the
terms of the Authorization. Notice of the issuance of this
Authorization was published in the Federal Register on July 23, 2021
(86 FR 39040), 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. Authorization Revocation Requests
In a request received by FDA on February 7, 2023, Babson
Diagnostics, Inc., requested the revocation of, and on February 14,
2023, FDA revoked, the Authorization for the Babson Diagnostics aC19G1.
Because Babson Diagnostics, Inc., notified FDA that it is no longer
offering the Babson Diagnostics aC19G1and requested FDA revoke the
Babson Diagnostics aC19G1, FDA has determined that it is appropriate to
protect the public health or safety to revoke this Authorization.
In a request received by FDA on January 27, 2023, Twist Bioscience
Corporation requested withdrawal of, and on February 14, 2023, FDA
revoked, the Authorization for the SARS-CoV-2 NGS Assay. Because Twist
Bioscience Corporation notified FDA that it will no longer be using the
SARS-CoV-2 NGS Assay and requested FDA withdraw the Authorization for
the SARS-CoV-2 NGS Assay, 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 EUA of Babson Diagnostics, Inc., for the Babson
Diagnostics aC19G1 and of Twist Bioscience Corporation for the SARS-
CoV-2 NGS 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: March 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-04845 Filed 3-8-23; 8:45 am]
BILLING CODE 4164-01-P
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