Rules and Regulations. Notice

Agency: Food and Drug Administration, HHS
Action: Notice
Citation: FR Doc. 2023-08281 · Docket No. FDA-2023-N-1378

Summary

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to BioFire Defense, LLC, for the FilmArray NGDS BT-E Assay, and Biocartis NV, for the Idylla Rapid Ebola Virus Triage Test. 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 revocation of the Authorization for the BioFire Defense, LLC's FilmArray NGDS BT-E Assay is effective as of March 8, 2023. The revocation of the Authorization for the Biocartis NV's Idylla Rapid Ebola Virus Triage Test is effective as of March 9, 2023.

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 October 25, 2014, FDA issued the Authorization to BioFire Defense, LLC, for the FilmArray NGDS BT-E Assay, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on February 9, 2015 (80 FR 6972), as required by section 564(h)(1) of the FD&C Act. On May 26, 2016, FDA issued the Authorization to Biocartis NV, for the Idylla Rapid Ebola Virus Triage Test, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on July 8, 2016 (81 FR 44616), 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 24, 2023, BioFire Defense, LLC, requested the revocation of, and on March 8, 2023, FDA revoked, the Authorization for the BioFire Defense, LLC's FilmArray NGDS BT-E Assay. Because BioFire Defense, LLC, notified FDA that it is obsolescing the FilmArray NGDS BT-E Assay and requested FDA withdraw the BioFire Defense, LLC's, FilmArray NGDS BT-E Assay, 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 November 23, 2022, Biocartis US, Inc., on behalf of Biocartis NV, requested rescission of, and on March 9, 2023, FDA revoked, the Authorization for the Idylla Rapid Ebola Virus Triage Test. Because Biocartis US, Inc., on behalf of Biocartis NV, notified FDA that it has discontinued the production of Idylla Rapid Ebola Virus Triage Test and requested FDA rescind the Authorization for the Idylla Rapid Ebola Virus Triage Test, 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 BioFire Defense, LLC's FilmArray NGDS BT-E Assay and of Biocartis NV's Idylla Rapid Ebola Virus Triage Test. 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 4161-01-P EN20AP23.004 EN20AP23.005 Dated: April 14, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023-08281 Filed 4-19-23; 8:45 am]