86 Fed. Reg. 48712 (Aug. 31, 2021)

Revocation of Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability

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Federal RegisterAug 31, 2021

86 Fed. Reg. 48712 (Aug. 31, 2021)

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 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, 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.

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.

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;
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.