[Federal Register Volume 85, Number 5 (Wednesday, January 8, 2020)]
[Notices]
[Pages 910-915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00063]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-5801]


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.

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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

[[Page 911]]

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.
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    Dated: January 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00063 Filed 1-7-20; 8:45 am]
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