[Federal Register Volume 85, Number 234 (Friday, December 4, 2020)]
[Notices]
[Pages 78339-78344]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26697]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-2216]
Revocation of Authorizations of Emergency Use of Certain Medical
Devices During COVID-19; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocations of the Emergency Use Authorizations (EUAs) (the
Authorizations) issued to Manufacturers of Protective Barrier
Enclosures and Other Stakeholders for certain protective barrier
enclosures (``PBE Authorization'') and to Manufacturers of Infusion
Pumps and Infusion Pump Accessories and Other Stakeholders for certain
infusion pumps and infusion pump accessories (``Infusion Pump
Authorization''). FDA revoked the PBE Authorization on August 20, 2020,
and the Infusion Pump Authorization on September 21, 2020, under the
Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, which
include an explanation of the reasons for each revocation, are
reprinted in this document.
DATES: The PBE Authorization is revoked as of August 20, 2020. The
Infusion Pump Authorization is revoked as of September 21, 2020.
ADDRESSES: Submit written requests for single copies of the revocations
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 revocations may be sent. See the SUPPLEMENTARY INFORMATION section
for electronic access to the revocations.
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) 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 May 1, 2020, FDA issued the PBE Authorization. On May
13, 2020, FDA issued the Infusion Pump Authorization. Of note, these
were both ``umbrella'' Authorizations, i.e., for certain types of
products that met the requirements as described in their respective
Authorizations. Any product with an individual Authorization is not
affected by revocation of these two umbrella Authorizations. Notice of
the issuance of the Authorizations was published in the Federal
Register on July 14, 2020 (85 FR 42407), as required by section
564(h)(1) of the FD&C Act. Subsequent to the issuance of the PBE
Authorization, FDA considered new information, specifically from new
preliminary evidence from simulated intubation procedure models of
potential adverse events that could occur or complications with
protective barrier enclosures without negative pressure. Subsequent to
the issuance of the Infusion Pump Authorization, FDA considered that no
device had been listed under the EUA and that circumstances instead
support allowing for tailored requirements of authorization in
individual EUAs.
II. EUA Criteria for Issuance No Longer Met and Other Circumstances
Make Revocation Appropriate To Protect the Public Health or Safety
Under section 564(g)(2)(B) and (C) of the FD&C Act, the Secretary
of the Department of Health and Human Services may revoke an EUA if,
among other things, the criteria for issuance are no longer met or
other circumstances make such revocation appropriate to protect the
public health or safety. On August 20, 2020, FDA revoked the PBE
Authorization because the criteria for issuance were no longer met and
other circumstances make such revocation appropriate to protect the
public health or safety. Under section 564(c)(2) of the FD&C Act, an
EUA may be issued only if FDA concludes that, based on the totality of
scientific evidence available, including data from adequate and well-
controlled clinical trials, if available, it is reasonable to believe
that the product may be effective in diagnosing, treating, or
preventing such disease or condition and that the known and potential
benefits of the product, when used to diagnose, prevent, or treat such
disease or condition, outweigh the known and potential risks of the
product.
Given the new preliminary evidence from simulated intubation
procedure models of potential adverse events that could occur or
complications with protective barrier enclosures without negative
pressure recently reported in literature articles, FDA has concluded it
is not reasonable to believe the product may be effective in decreasing
healthcare provider exposure to airborne particles and may instead
contribute to an increase in healthcare provider exposure to airborne
particles. Additionally, the literature articles note potential risks
of protective barrier enclosures, such as increased intubation times,
lower first-pass intubation success rates, damage to personal
protective equipment from intubation boxes, particles escaping from
intubation boxes through arm access holes reaching the face of the
healthcare provider performing the endotracheal intubation, and human
factors issues contributing to increased endotracheal intubation times.
Further, based on the same information and the risks to public health,
including from the device's potential contribution to an increase in
healthcare provider exposure to airborne particles, FDA has concluded
under section 564(g)(2)(C) of the FD&C Act that other circumstances
make revocation appropriate to protect the public health or safety.
Accordingly, FDA has revoked the PBE
[[Page 78340]]
Authorization, pursuant to section 564(g)(2)(B) and (C) of the FD&C
Act.
On September 21, 2020, FDA revoked the Infusion Pump Authorization
because other circumstances make such revocation appropriate to protect
the public health or safety (section 564(g)(2)(C) of the FD&C Act),
considering that no device has been listed under the EUA, and
circumstances instead support allowing for tailored requirements of
authorization in individual EUAs.
III. Electronic Access
An electronic version of this document and the full text of the
revocations are available on the internet at https://www.regulations.gov, and https://www.fda.gov/media/142374/download and
https://www.fda.gov/media/141415/download.
IV. The Revocations
Having concluded that the criteria for revocation of the
Authorizations under section 564(g) of the FD&C Act are met, FDA has
revoked the EUAs for certain protective barrier enclosures and certain
infusion pumps and infusion pump accessories. 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: November 30, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26697 Filed 12-3-20; 8:45 am]
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