[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


