2020-00063. Revocation of Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of and/or Diagnosis of Zika or Ebola Virus

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the revocation of three Emergency Use Authorizations (EUAs) (the Authorizations) issued to OraSure Technologies, Inc. (OraSure) for the OraQuick Ebola Rapid Antigen Test used with whole blood specimens; OraSure for the OraQuick Ebola Rapid Antigen Test used with cadaveric oral fluid swab specimens; and DiaSorin Inc. (DiaSorin) for the LIAISON XL Zika Capture IgM II assay. FDA revoked both of OraSure's Authorizations on October 10, 2019, under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), in consideration of a De Novo classification request granted to OraSure for the OraQuick Ebola Rapid Antigen Test on October 10, 2019. FDA revoked DiaSorin's Authorization on October 28, 2019, under the FD&C Act, in consideration of the premarket clearance of DiaSorin's LIAISON XL Zika Capture IgM II assay, which FDA determined to be substantially equivalent to a legally marketed class II predicate device on October 28, 2019. The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document.

DATES:

OraSure's Authorizations are revoked as of October 10, 2019. DiaSorin's Authorization is revoked as of October 28, 2019.

ADDRESSES:

Submit written requests for single copies of the revocation(s) 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.

First, on July 31, 2015, FDA issued an EUA to OraSure for the OraQuick Ebola Rapid Antigen Test used with whole blood specimens, subject to the terms of the Authorization. Notice of the issuance of the Authorization was published in the Federal Register on September 14, 2015 (80 FR 55125), as required by section 564(h)(1) of the FD&C Act. In response to requests from OraSure, this EUA was amended on March 18, 2016, and January 30, 2019.

Second, on March 4, 2016, FDA issued an EUA to OraSure for the OraQuick Ebola Rapid Antigen Test used with cadaveric oral fluid, subject to the terms of the Authorization. Notice of the issuance of the Authorization was published in the Federal Register on April 22, 2016 (81 FR 23709), as required by section 564(h)(1) of the FD&C Act. In response to requests from OraSure, this EUA was amended on November 14, 2016, and February 1, 2019. Subsequently, on October 10, 2019, FDA granted a De Novo classification request for the OraQuick Ebola Rapid Antigen Test under the generic name “Device to detect antigens of biothreat microbial agents in human clinical specimens,” as Class II (special controls) under product code QID (https://www.accessdata.fda.gov/​cdrh_​docs/​pdf19/​DEN190025.pdf).

Third, on April 5, 2017, FDA issued an EUA to DiaSorin for the LIAISON XL Zika Capture IgM II assay, subject to the terms of the Authorization. Notice of the issuance of the Authorization was published in the Federal Register on June 30, 2017 (82 FR 29886), and corrected on July 10, 2017 (82 FR 31783), as required by section 564(h)(1) of the FD&C Act. In response to requests from DiaSorin, this EUA was amended on November 6, 2017, and December 27, 2018. Subsequently, DiaSorin submitted a premarket notification to FDA for the LIAISON XL Zika Capture IgM II assay. On October 28, 2019, FDA determined that the LIAISON XL Zika Capture IgM II assay was substantially equivalent to a legally marketed class II predicate device under product code QFO with the generic name “Zika virus serological reagents” (https://www.accessdata.fda.gov/​cdrh_​docs/​pdf19/​K192046.pdf).

II. EUA Criteria for Issuance No Longer Met

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. 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. On October 10, 2019, FDA revoked the EUAs for OraSure's OraQuick Ebola Rapid Antigen Test for use with whole blood specimens and cadaveric oral fluid, and on October 28, 2019, FDA revoked the EUA for DiaSorin's LIAISON XL Zika Capture IgM II assay because the criteria for issuance were no longer met. FDA determined that the criteria for issuance of OraSure's two Authorizations are no longer met because OraSure had a De Novo classification request granted for the OraQuick Ebola Rapid Antigen Test as a Class II device under the generic name “Device to detect antigens of biothreat microbial agents in human clinical specimens” on October 10, 2019.

FDA also determined that the criteria for issuance of DiaSorin's Authorization are no longer met because the LIAISON XL Zika Capture IgM II assay was determined to be substantially equivalent to a legally marketed class II predicate device with the generic name “Zika virus serological reagents.” As such, in each case FDA concluded that there is an adequate, approved, and available alternative for purposes of section 564(c)(3) of the FD&C Act and accordingly revoked the Authorizations pursuant to section 564(g)(2)(B) of the 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 Revocations

Having concluded that the criteria for revocations of the Authorizations under section 564(g) of the FD&C Act are met, FDA has revoked the EUAs for OraSure's OraQuick Ebola Rapid Antigen Test for use with whole blood specimens and cadaveric oral fluid and for DiaSorin's LIAISON XL Zika Capture IgM II assay. The revocations in their entirety follow and provide an explanation of the reasons for each revocation, as required by section 564(h)(1) of the FD&C Act.

Dated: January 2, 2020.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.