[Federal Register Volume 84, Number 152 (Wednesday, August 7, 2019)]
[Notices]
[Pages 38636-38638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16881]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocation of the Emergency Use Authorization (EUA) (the Authorization)
issued to InBios International, Inc. (InBios), for the ZIKV Detect 2.0
IgM Capture ELISA. FDA revoked this Authorization on May 23, 2019,
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), in
consideration of the De Novo classification request granted to the
InBios ZIKV Detect 2.0 IgM Capture ELISA as a Class II device under the
generic name Zika virus serological reagents on May 23, 2019. The
revocation, which includes an explanation of the reasons for
revocation, is reprinted in this document.
DATES: The Authorization is revoked as of May 23, 2019.
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 (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 August 17, 2016, FDA issued
an EUA to InBios for the ZIKV Detect 2.0 IgM Capture ELISA, subject to
the terms of the Authorization. Notice of the issuance of the
Authorization was published in the Federal Register on October 28, 2016
(81 FR 75092), as required by section 564(h)(1) of the FD&C Act. In
response to requests from InBios, the EUA was amended on March 27,
2017, and May 18, 2018. Under section 564(g)(2) of the FD&C Act, the
Secretary of Health and Human Services (HHS) may revoke an EUA if,
among other things, the criteria for issuance are no longer met.
II. EUA Criteria for Issuance No Longer Met
On March 23, 2019, FDA revoked the EUA for the InBios ZIKV Detect
2.0 IgM Capture ELISA 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. The InBios ZIKV Detect 2.0 IgM Capture ELISA had
a De Novo classification request granted as a Class II device under the
generic name Zika virus serological reagents on May 23, 2019 (https://www.accessdata.fda.gov/cdrh_docs/pdf18/DEN180069.pdf). FDA has
concluded that this is an adequate, approved, and available alternative
for diagnosing Zika virus infection.
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/.
[[Page 38637]]
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 the InBios ZIKV Detect 2.0 IgM Capture ELISA. 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.
BILLING CODE 4164-01-P
[GRAPHIC] [TIFF OMITTED] TN07AU19.000
[[Page 38638]]
[GRAPHIC] [TIFF OMITTED] TN07AU19.001
Dated: August 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16881 Filed 8-6-19; 8:45 am]
BILLING CODE 4164-01-C