Revocation of Authorizations of Emergency Use of Certain Medical Devices During COVID-19; Availability, 78339-78344 [2020-26697]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[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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