2018-16537. Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola 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 Zalgen Labs, LLC for the ReEBOV Antigen Rapid Test. FDA revoked this Authorization on May 18, 2018, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as requested by Zalgen Labs, LLC by letter dated March 1, 2018. The revocation, which includes an explanation of the reasons for revocation, is reprinted in this document.

DATES:

The Authorization is revoked as of May 18, 2018.

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:

Michael Mair, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4336, Silver Spring, MD 20993-0002, 301-796-8510 (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 February 24, 2015, FDA issued an EUA to Corgenix, Inc. for the ReEBOV Antigen Rapid Test, subject to the terms of the Authorization. Notice of the issuance of the Authorization was published in the Federal Register on June 5, 2015 (80 FR 32140), as required by section 564(h)(1) of the FD&C Act. In response to requests from Zalgen Labs, LLC and Corgenix, Inc. to transfer ownership of the EUA for the ReEBOV Antigen Rapid Test from Corgenix, Inc. to Zalgen Labs, LLC, FDA amended and reissued the EUA to Zalgen Labs, LLC in its entirety on November 3, 2016. Under section 564(g)(2), the Secretary of Health and Human Services 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 Ebola Virus

Pursuant to a request from Zalgen Labs, LLC on March 1, 2018, FDA revoked the EUA for the ReEBOV Antigen Rapid Test on May 18, 2018, because the criteria for issuance were no longer met and these circumstances made such 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 Zalgen Labs, LLC's ReEBOV Antigen Rapid 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.

Dated: July 27, 2018.

Leslie Kux,

Associate Commissioner for Policy.