Document ID: FDA-2022-N-0150-0008
Agency: fda
Document Type: Notice
Title: Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic
Devices for Detection and/or Diagnosis of COVID–19; Availability
Posted Date: 2023-03-09T05:00Z

[Federal Register Volume 88, Number 46 (Thursday, March 9, 2023)]
[Notices]
[Pages 14622-14625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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).

[[Page 14623]]

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 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 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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[GRAPHIC] [TIFF OMITTED] TN09MR23.008

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[GRAPHIC] [TIFF OMITTED] TN09MR23.009

    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