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  4. Enforcement Policy for Bioburden Reduction Systems Using Dry Heat to Support Single-User Reuse of Certain Filtering Facepiece Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
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GUIDANCE DOCUMENT

Enforcement Policy for Bioburden Reduction Systems Using Dry Heat to Support Single-User Reuse of Certain Filtering Facepiece Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance for Industry, Healthcare Organizations, Healthcare Personnel, and Food and Drug Administration Staff November 2020

Final Level 1 Guidance
Docket Number:
FDA-2020-D-1138
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. 

FDA is issuing this guidance to provide a policy for bioburden1 reduction systems that use dry heat to help support the single-user reuse2 of certain particulate filtering facepiece respirators3 (FFRs). This policy applies to FFRs that do not have exhalation valves, do not incorporate a duck-bill design, and do not contain antimicrobial/antiviral agents and 1) have been authorized under the emergency use authorization (EUA) for NIOSH-approved FFRs,4 or 2) have been authorized under the EUA for non-NIOSH-approved FFRs that are not manufactured in China,5 or 3) are FDA-cleared as intended for use by healthcare personnel (HCP)6 ("compatible respirators" or "compatible FFRs"). Bioburden reduction systems play an important role in the ongoing efforts to help address shortages of FFRs intended for a medical purpose or used as personal protective equipment (PPE) by HCP for the duration of the COVID-19 public health emergency.

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)).

Given this public health emergency, and as discussed in the Notice in the Federal Register of March 25, 2020, titled "Process for Making Available Guidance Documents Related to Coronavirus Disease 2019," this guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency's good guidance practices.


1 The term "bioburden" is commonly used to describe the population of viable microorganisms on a product and/or a sterile barrier system.

2 For the purposes of this guidance, "single-user" means that the same person should use the respirator following bioburden reduction.

3 For the purposes of this guidance, the terms "respirators" and "filtering facepiece respirators" (FFRs) are used interchangeably.

4 Letter of Authorization regarding "NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency.".

5 Letter of Authorization regarding "Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators."

6 As used in the two emergency use authorizations (EUAs) for FFRs that may be relevant under this policy and in effect at the time of publication of this guidance, healthcare personnel (HCP) refers to all paid and unpaid persons serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials, including body substances (e.g., blood, tissue, and specific body fluids); contaminated medical supplies, devices, and equipment; contaminated environmental surfaces; or contaminated air. These HCP include, but are not limited to, emergency medical service personnel, nurses, nursing assistants, physicians, technicians, therapists, phlebotomists, pharmacists, dentists and dental hygienists, students and trainees, contractual staff not employed by the healthcare facility, and persons not directly involved in patient care, but who could be exposed to infectious agents that can be transmitted in the healthcare setting (e.g., clerical, dietary, environmental services, laundry, security, engineering and facilities management, administrative, billing, and volunteer personnel).


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-1138.

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