Document ID: FDA-2019-N-3277-0004
Agency: fda
Document Type: Notice
Title: Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection and/or Diagnosis of Zika Virus
Posted Date: 2020-07-24T04:00Z

[Federal Register Volume 85, Number 143 (Friday, July 24, 2020)]
[Notices]
[Pages 44908-44911]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16014]

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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 Chembio Diagnostic Systems, Inc. (``Chembio'') for the DPP 
Zika IgM Assay System. FDA revoked this Authorization on June 3, 2020, 
under

[[Page 44909]]

the Federal Food, Drug, and Cosmetic Act (FD&C Act), in consideration 
of the premarket notification clearance by FDA for the DPP Zika IgM 
System, DPP Zika IgM System Control Pack, and DPP Micro Reader that was 
determined to be substantially equivalent to a legally marketed class 
II predicate device on June 3, 2020. The revocation, which includes an 
explanation of the reasons for revocation, is reprinted in this 
document.

DATES: The Authorization is revoked as of June 3, 2020.

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.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) 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 27, 2017, FDA issued an EUA to Chembio, for 
the DPP Zika IgM Assay System, 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 Chembio, the EUA was amended on February 6, 2018, and 
August 3, 2018. Subsequently, on June 3, 2020, Chembio submitted a 
premarket notification to FDA for the DPP Zika IgM System, DPP Zika IgM 
System Control Pack, and DPP Micro Reader (K200506), that was 
determined to be substantially equivalent to a legally marketed Class 
II predicate device.

II. EUA Criteria for Issuance No Longer Met

    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. On June 3, 2020, FDA revoked 
the EUA for Chembio's DPP Zika IgM Assay System 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 Chembio's DPP Zika 
IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader was 
determined on June 3, 2020, to be substantially equivalent to a legally 
marketed class II predicate device with the generic name ``Zika virus 
serological reagents.'' 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 Chembio's DPP Zika IgM Assay System. 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: July 17, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-16014 Filed 7-23-20; 8:45 am]
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