[Federal Register Volume 84, Number 179 (Monday, September 16, 2019)]
[Notices]
[Pages 48625-48628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19982]


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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 Siemens Healthcare Diagnostics, Inc. (Siemens), for the ADVIA 
Centaur Zika test. FDA revoked this Authorization on July 17, 2019, 
under the Federal Food, Drug, and Cosmetic Act (FD&C Act), in 
consideration of the premarket notification submission submitted to FDA 
by Siemens for the ADVIA Centaur Zika test that was determined to be 
substantially equivalent to a legally marketed class II predicate 
device on July 17, 2019. The revocation, which includes an explanation 
of the reasons for revocation, is reprinted in this document.

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DATES: The Authorization is revoked as of July 17, 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 September 18, 2017, FDA 
issued an EUA to Siemens, for the ADVIA Centaur Zika test, subject to 
the terms of the Authorization. Notice of the issuance of the 
Authorization was published in the Federal Register on November 17, 
2017 (82 FR 54361), as required by section 564(h)(1) of the FD&C Act. 
In response to requests from Siemens, the EUA was amended on November 
16, 2017, and April 18, 2019. Subsequently, on May 23, 2019, FDA 
classified a de novo application for a generic Zika virus serological 
reagents device as Class II (special controls) under product code QFO 
(https://www.accessdata.fda.gov/cdrh_docs/pdf18/DEN180069.pdf). Under 
section 564(g)(2) of the FD&C Act, the Secretary of Health and Human 
Services may revoke an EUA if, among other things, the criteria for 
issuance are no longer met.

II. EUA Criteria for Issuance No Longer Met

    On July 17, 2019, FDA revoked the EUA for Siemens' ADVIA Centaur 
Zika test because the criteria for issuance were no longer met. Under 
section 564(c)(3) of the FD&C Act, an EUA may be issued only if FDA 
concludes there is no adequate, approved, and available alternative to 
the product for diagnosing, preventing, or treating the disease or 
condition. FDA has determined that the criteria for issuance of such 
authorization under section 564(c)(3) of the FD&C Act are no longer met 
because Siemens' ADVIA Centaur Zika test was determined on July 17, 
2019, to be substantially equivalent to a legally marketed class II 
predicate device with the generic name ``Zika virus serological 
reagents'' (https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191578.pdf). As such, FDA concluded that there is an adequate, 
approved, and available alternative for diagnosing Zika virus infection 
for purposes of section 564(c)(3) of the FD&C Act and accordingly 
revoked the Authorization pursuant to section 564(g)(2)(B) of the FD&C 
Act.

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 Siemens' ADVIA Centaur Zika test. 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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    Dated: September 11, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-19982 Filed 9-13-19; 8:45 am]
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