Document ID: FDA-2023-N-4202-0001
Agency: fda
Document Type: Notice
Title: Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of Mpox; Availability
Posted Date: 2023-10-10T04:00Z

[Federal Register Volume 88, Number 194 (Tuesday, October 10, 2023)]
[Notices]
[Pages 69932-69935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22390]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-4202]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
revocations of the Emergency Use Authorizations (EUAs) (the 
Authorizations) issued to Life Technologies Corp. (a part of Thermo 
Fisher Scientific Inc.), for the TaqPath Monkeypox/Orthopox Virus DNA 
Kit, and Becton, Dickinson and Co., for the VIASURE Monkeypox virus 
Real Time PCR Reagents for BD MAX System. FDA revoked these 
Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) as requested by these Authorization holders. The revocations, 
which include an explanation of the reasons for each revocation, are 
reprinted in this document.

DATES: The Authorization for the Life Technologies Corp. (a part of 
Thermo

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Fisher Scientific Inc.)'s, TaqPath Monkeypox/Orthopox Virus DNA Kit is 
revoked as of April 18, 2023. The Authorization for the Becton, 
Dickinson and Co.'s, VIASURE Monkeypox virus Real Time PCR Reagents for 
BD MAX System is revoked as of May 24, 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, radiological, or nuclear agent or 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 December 13, 2022, 
FDA issued the Authorization to Life Technologies Corp. (a part of 
Thermo Fisher Scientific Inc.) for the TaqPath Monkeypox/Orthopox Virus 
DNA Kit, subject to the terms of the Authorization. Notice of the 
issuance of this Authorization was published in the Federal Register on 
January 11, 2023 (88 FR 1587), as required by section 564(h)(1) of the 
FD&C Act. On December 23, 2022, FDA issued the Authorization to Becton, 
Dickinson and Co. for the VIASURE Monkeypox virus Real Time PCR 
Reagents for BD MAX System subject to the terms of the Authorization. 
Notice of the issuance of this Authorization was published in the 
Federal Register on January 31, 2023 (88 FR 6262), 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. Authorizations Revocation Request

    In a request received by FDA on April 13, 2023, Life Technologies 
Corp. (a part of Thermo Fisher Scientific Inc.), requested the 
revocation of, and on April 18, 2023, FDA revoked, the Authorization 
for the Life Technologies Corp. (a part of Thermo Fisher Scientific 
Inc.)'s TaqPath Monkeypox/Orthopox Virus DNA Kit. Because Life 
Technologies Corp. (a part of Thermo Fisher Scientific Inc.), notified 
FDA that it is not commercially supporting the TaqPath Monkeypox/
Orthopox Virus DNA Kit and no kit reagents were distributed in the 
United States and requested FDA revoke the Life Technologies Corp. (a 
part of Thermo Fisher Scientific Inc.)'s TaqPath Monkeypox/Orthopox 
Virus DNA Kit, 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 May 22, 2023, Becton, Dickinson and 
Co., requested the withdrawal of, and on May 24, 2023, FDA revoked, the 
Authorization for the Becton, Dickinson and Co.'s VIASURE Monkeypox 
virus Real Time PCR Reagents for BD MAX System. Because Becton, 
Dickinson and Co., notified FDA that it is not commercially 
manufacturing the VIASURE Monkeypox virus Real Time PCR Reagents for BD 
MAX System and no reagents were distributed in the United States and 
requested FDA revoke the Becton, Dickinson and Co.'s VIASURE Monkeypox 
virus Real Time PCR Reagents for BD MAX System, 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 
Authorization under section 564(g)(2)(C) of the FD&C Act are met, FDA 
has revoked the EUA of Life Technologies Corp. (a part of Thermo Fisher 
Scientific Inc.)'s TaqPath Monkeypox/Orthopox Virus DNA Kit, and 
Becton, Dickinson and Co.'s VIASURE Monkeypox virus Real Time PCR 
Reagents for BD MAX System. The revocations in their entirety follow 
and provide an explanation of the reasons for revocations, as required 
by section 564(h)(1) of the FD&C Act.
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    Dated: October 4, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22390 Filed 10-6-23; 8:45 am]
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