2023-04845. 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.

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).

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.

Dated: March 6, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.