Notice2023-08281
Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of Ebola; Availability
Primary source
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Published
April 20, 2023
Effective
March 8, 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 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.
Full Text
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<title>Federal Register, Volume 88 Issue 76 (Thursday, April 20, 2023)</title>
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[Federal Register Volume 88, Number 76 (Thursday, April 20, 2023)]
[Notices]
[Pages 24425-24427]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>.
[[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.
BILLING CODE 4161-01-P
[GRAPHIC] [TIFF OMITTED] TN20AP23.004
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Dated: April 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08281 Filed 4-19-23; 8:45 am]
BILLING CODE 4161-01-C
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