Document ID: FDA-2023-N-1378-0001
Agency: fda
Document Type: Notice
Title: Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of Ebola; Availability
Posted Date: 2023-04-20T04:00Z

[Federal Register Volume 88, Number 76 (Thursday, April 20, 2023)]
[Notices]
[Pages 24425-24427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08281]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-1378]

Revocation of Two Authorizations of Emergency Use of In Vitro 
Diagnostic Devices for Detection and/or Diagnosis of Ebola; 
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 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.

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 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/.

[[Page 24426]]

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.
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[GRAPHIC] [TIFF OMITTED] TN20AP23.005

    Dated: April 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08281 Filed 4-19-23; 8:45 am]
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