Document ID: FDA-2019-N-3277-0003
Agency: fda
Document Type: Notice
Title: Revocation of Authorization of Emergency Use of an In Vitro
Diagnostic Device for Detection and/or Diagnosis of Zika Virus
Posted Date: 2019-09-19T04:00Z

[Federal Register Volume 84, Number 182 (Thursday, September 19, 2019)]
[Notices]
[Pages 49314-49316]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20327]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3277]

Revocation of Authorization of Emergency Use of an In Vitro 
Diagnostic Device for Detection and/or Diagnosis of Zika Virus

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 Authorization (EUA) (the Authorization) 
issued to Luminex Corp., for the xMAP MultiFLEX Zika RNA Assay. FDA 
revoked this Authorization on July 3, 2019, under the Federal Food, 
Drug, and Cosmetic Act (FD&C Act), as requested by Luminex Corp. by a 
letter dated June 18, 2019. The revocation, which includes an 
explanation of the reasons for revocation, is reprinted in this 
document.

DATES: The Authorization is revoked as of July 3, 2019.

ADDRESSES: Submit written requests for single copies of the revocation 
to the Office of Counterterrorism and Emerging Threats, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, 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 revocation may be sent. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the revocation.

FOR FURTHER INFORMATION CONTACT: Jennifer J. Ross, Office of 
Counterterrorism and Emerging Threats, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002, 240-402-8155 (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 August 4, 2016, FDA issued an 
EUA to Luminex Corp. for the xMAP MultiFLEX Zika RNA Assay, subject to 
the terms of the Authorization. Notice of the issuance of the 
Authorization was published in the Federal Register on October 28, 2016 
(81 FR 75092), as required by section 564(h)(1) of the FD&C Act. In 
response to requests from Luminex Corp., the EUA was amended on January 
7, 2017, and May 19, 2017. Under section 564(g)(2) of the FD&C Act, the 
Secretary of HHS may revoke an EUA if, among other things, the criteria 
for issuance are no longer met or other circumstances make such 
revocation appropriate to protect the public health or safety.

II. EUA Revocation Request for an In Vitro Diagnostic Device for 
Detection of the Zika Virus

    On June 18, 2019, Luminex Corp. requested, and on July 3, 2019, FDA 
revoked, the EUA for the xMAP MultiFLEX Zika RNA Assay because the 
product will no longer be marketed, and these circumstances make 
revocation appropriate to protect the public health or safety.

III. Electronic Access

    An electronic version of this document and the full text of the 
revocation are available on the internet at https://www.regulations.gov/.

IV. The Revocation

    Having concluded that the criteria for revocation of the 
Authorization under section 564(g) of the FD&C Act are met, FDA has 
revoked the EUA for Luminex Corp.'s xMAP MultiFLEX Zika RNA Assay. The 
revocation in its entirety follows and provides an explanation of the 
reasons for revocation, as required by section 564(h)(1) of the FD&C 
Act.

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[GRAPHIC] [TIFF OMITTED] TN19SE19.019

[[Page 49316]]

    Dated: September 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20327 Filed 9-18-19; 8:45 am]
 BILLING CODE 4164-01-P