[Federal Register Volume 86, Number 166 (Tuesday, August 31, 2021)]
[Notices]
[Pages 48712-48736]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18777]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0762]
Revocation of Authorization 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
revocation of 15 Emergency Use Authorizations (EUAs) (the
Authorizations), including 12 Authorizations for decontamination
systems for personal protective equipment, 1 Authorization for a
bioburden reduction system for personal protective equipment, and 2
umbrella Authorizations for certain imported, non-NIOSH (National
Institute of Occupational Safety and Health)-approved disposable
respirators. FDA revoked the Authorizations for the decontamination and
bioburden reduction systems for personal protective equipment on June
30, 2021, under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as
requested by each Authorization holder. FDA revoked the umbrella
Authorizations issued to manufacturers and other stakeholders of
imported non-NIOSH approved filtering facepiece respirators
manufactured in China (China FFR Authorization), and to manufacturers
and other stakeholders of imported non-NIOSH approved filtering
facepiece respirators (Imports FFR Authorization) on June 30, 2021,
under the FD&C Act. The revocations, which each include an explanation
of the reasons for the revocation, are reprinted in this document.
DATES: The Authorizations for the decontamination and bioburden
reduction systems are revoked as of June 30, 2021. The Authorizations
for the China FFR Authorization and Imports FFR Authorization are
revoked as of July 6, 2021.
ADDRESSES: Submit written requests for a single copy 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 revocation may be sent. See the SUPPLEMENTARY INFORMATION section
for electronic access to the revocations.
FOR FURTHER INFORMATION CONTACT: Michael Mair, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4340, Silver Spring, MD 20993-
0002, 301-796-8510 (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. Notice of the issuance of the Authorizations was published
in the Federal Register as follows, as required by section 564(h)(1) of
the FD&C Act: (1) Published June 5, 2020 (85 FR 34638) for Imports FFR
Authorization (Certain Imported, Non-NIOSH-Approved Disposable
Filtering Facepiece Respirators) issued March 24, 2020; China FFR
Authorization (Certain Non-NIOSH-Approved Disposable Filtering
Facepiece Respirators Manufactured in China) issued April 3, 2020; and
STERIS Corporation for the STERIS Sterilization Systems (STERIS V-PRO 1
Plus, maX, and maX2 Low Temperature Sterilization Systems) issued April
9, 2020; (2) published July 14, 2020 (85 FR 42407) for Advanced
Sterilization Products, Inc. for the ASP STERRAD Decontamination
Systems issued April 11, 2020; Stryker
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Instruments for the STERIZONE VP4 Sterilizer issued April 14, 2020;
Sterilucent, Inc. for the Sterilucent HC 80TT Hydrogen Peroxide
Sterilizer issued April 20, 2020; Duke University Health System for the
Duke Decontamination System issued May 7, 2020; (3) published November
20, 2020, (85 FR 74346) for STERIS Corporation for the AMSCO Medium
Steam Sterilizers + the STERIS STEAM Decon Cycle issued May 21, 2020;
Stryker Sustainability Solutions (SSS) for the SSS VHP N95 Respirator
Decontamination System issued May 27, 2020; Technical Safety Services
LLC for the 20-CS Decontamination System issued June 13, 2020; MSU for
the MSU Decontamination System issued July 24, 2020; (4) published
April 23, 2021, (86 FR 21749) for Roxby Development, LLC for the Zoe-
Ann Decontamination System issued October 20, 2020; 3B Medical, Inc.
for the Lumin LM3000 Bioburden Reduction UV System issued December 3,
2020; Ecolab Inc. for the Bioquell Technology System issued December 4,
2020; and Yale New Haven Health System for the Yale New Haven Health
FILTERING FACEPIECE RESPIRATOR Decontamination System issued January
15, 2021.
Any subsequent reissuances of the Authorizations are listed in the
revocation letters reprinted at the end of this document.
The authorization of a device for emergency use under section 564
of the FD&C Act may, pursuant to section 564(g)(2) of the FD&C Act, be
revoked when the criteria under section 564(c) of the FD&C Act for
issuance of such authorization are no longer met (section 564(g)(2)(B)
of the FD&C Act), or other circumstances make such revocation
appropriate to protect the public health or safety (section
564(g)(2)(C) of the FD&C Act).
II. EUA Revocation Criteria Met
On June 30, 2021, FDA revoked the China FFR Authorization and
Imports FFR Authorization. FDA reviewed the totality of scientific
evidence available, including data provided by device manufacturers,
distributors, Group Purchasing Organizations, FDA Imports database,
healthcare organizations, and Federal/State stockpiles. Based on the
change in the Centers for Disease Control and Prevention (CDC)
recommendations, the increase in availability of NIOSH-approved
respirators, the Occupational Safety and Health Administration (OSHA)
Emergency Temporary Standard (ETS) requirements, and information
provided by healthcare organizations and others,\1\ FDA has concluded
that the known and potential benefits of these respirators, when used
for such use, no longer outweigh the known and potential risks of
continued use, and pursuant to section 564(g)(2)(B), the criteria under
section 564(c) of the FD&C Act for issuance of the Authorizations are
no longer met. In addition, based on the same information, revocation
of the Authorizations is appropriate to protect the public health and
safety pursuant to section 564(g)(2)(C) of the FD&C Act.
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\1\ Non-NIOSH approved FFRs were previously recommended by CDC
as a crisis capacity strategy when there was a severe shortage of
NIOSH-approved FFRs available for healthcare personnel (HCP).
Available information now shows an increase in the current and
projected U.S. supply of NIOSH-approved respirators, including N95s
(https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/N95list1.html). As such, on April 9 and May 27, 2021, CDC updated
their recommendations to reflect that healthcare facilities should
return to conventional capacity strategies and thus CDC no longer
recommends the use of non-NIOSH-approved FFRs. On May 27, 2021, FDA
also recommended that healthcare facilities and HCP ``transition
away from crisis capacity conservation strategies, such as using
non-NIOSH-approved disposable respirators, including imported
respirators such as KN95s'' (https://www.fda.gov/medical-devices/letters-health-care-providers/update-fda-recommends-transition-use-non-niosh-approved-and-decontaminated-disposable-respirators). In
addition, on June 21, 2021 (86 FR 32376), OSHA issued an Emergency
Temporary Standard (ETS) to adequately address the hazard of COVID-
19 for HCP. The ETS requires, among other things, healthcare
employers to provide NIOSH-approved or FDA-authorized respirators
for healthcare workers potentially exposed to COVID-19.
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On June 30, 2021, FDA revoked the Authorizations for
decontamination and bioburden reductions systems pursuant to requests
from the following entities on the following dates:
April 9, 2021, from Duke for the Duke Decontamination
System;
April 15, 2021, from Sterilucent, Inc. for the Sterilucent
HC 80TT Hydrogen PeroxideSterilizer;
April 16, 2021, from Yale for the Yale New Haven Health
FFR Decontamination System;
May 13, 2021, from STERIS Corporation for the STERIS
Sterilization Systems, as well as the AMSCO Medium Steam Sterilizers +
the STERIS STEAM Decon Cycle;
May 25, 2021, from Stryker Sustainability Solutions (SSS)
for the SSS VHP N95 Respirator Decontamination System;
May 27, 2021 from MSU for the MSU Decontamination System;
June 4, 2021, from Advanced Sterilization Products, Inc.
for the ASP STERRAD Decontamination Systems;
June 7, 2021, from Technical Safety Services LLC for the
20-CS Decontamination System;
June 7, 2021, from Roxby Development, LLC for the Zoe-Ann
Decontamination System;
June 7, 2021, from 3B Medical, Inc. for the Lumin LM3000
Bioburden Reduction UV System;
June 7, 2021, from Ecolab Inc. for the Bioquell Technology
System; and
June 8, 2021, from Stryker Instruments for the STERIZONE
VP4 Sterilizer.
Because these entities notified FDA that they have ceased
operations and associated activities and request withdrawal of their
respective Authorizations, and consistent with FDA's belief that the
known and potential benefits of these systems, when used for their
emergency use, no longer outweigh the known and potential risks of such
use, FDA has determined that it is appropriate to revoke the
Authorizations because the criteria for issuance of an EUA under
section 564(c)(2)(B) of the Act are no longer met. Moreover, based on
the same information, 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.
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/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization-archived-information#covid19.
IV. The Revocations
Having concluded that the criteria for revocation of the
Authorizations under section 564(g)(2)(B) and 564(g)(2)(C) of the FD&C
Act are met, FDA has revoked the following Authorizations:
China FFR Authorization;
Imports FFR Authorization;
Duke's Duke Decontamination System;
Sterilucent, Inc.'s Sterilucent HC 80TT Hydrogen Peroxide
Sterilizer;
Yale's Yale New Haven Health FFR Decontamination System;
STERIS Corporation's STERIS Sterilization Systems, as well
as the AMSCO Medium Steam Sterilizers + the STERIS STEAM Decon Cycle;
Stryker Sustainability Solutions's SSS VHP N95 Respirator
Decontamination System;
MSU's MSU Decontamination System;
Advanced Sterilization Products, Inc.'s ASP STERRAD
Decontamination Systems;
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Technical Safety Services LLC's 20-CS Decontamination
System;
Roxby Development, LLC's Zoe-Ann Decontamination System;
3B Medical, Inc.'s Lumin LM3000 Bioburden Reduction UV
System;
Ecolab Inc.'s Bioquell Technology System; and
Stryker Instruments's STERIZONE VP4 Sterilizer.
The revocations in their entirety follow and provide an explanation
of the reasons for revocation, as required by section 564(h)(1) of the
FD&C Act.
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BILLING CODE 4164-01-C
Dated: August 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-18777 Filed 8-30-21; 8:45 am]
BILLING CODE 4164-01-P