[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
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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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