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.

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.

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.