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Decontaminating Respirators for 

Health Care Personnel Use during 

the COVID-19 Pandemic

Center for Devices and Radiological Health (CDRH)

U.S Food and Drug Administration (FDA)
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 Methods for decontamination and bioburden reduction of N95 

respirators

 Evidence of potential effectiveness 

 Recommendations/Observations and common challenges in 

Emergency Use Authorization (EUA) request submissions

Decontaminating Respirators for Health Care 

Personnel Use during the COVID-19 Pandemic
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Decontamination and Bioburden Reduction

Recommendations for Sponsors Requesting EUAs for Decontamination and 

Bioburden Reduction Systems for Surgical Masks and Respirators During the 

Coronavirus Disease (COVID-19) Public Health Emergency

 Evidence-Based Approach to Decontamination and Bioburden 

Reduction

 Overview of Tiered Approach for Decontamination and Bioburden 

Reduction Systems

 Recommended Content of Pre-EUA submissions and EUA requests
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 Hierarchy applicable to most established microbicidal processes

 Tiered approach for processes that follow hierarchy

 Recommend discussion with FDA for processes that do not follow this 

hierarchy (CDRH-COVID19-SurgicalMasks@fda.hhs.gov)

Evidence-Based Approach to 

Decontamination and Bioburden Reduction

Descending Order 

of Resistance

of Microorganisms to 

Germicidal Chemicals
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Tiered Approach for 

Decontamination and Bioburden Reduction Systems

TIER Name Intended Use Recommended Evidence of Decontamination

Tier 1 Decontamination of Surgical

Masks and/or Respirators for

Single- or Multiple-Users *

Multiple-Users or 

Single-Users

− > 6-log spore reduction of the most resistant 

spore for the proposed process OR

− > 6-log reduction of Mycobacterium species 

(e.g. M. terrae or M. abscesses

Tier 2 Decontamination of Surgical

Masks and/or Respirators for

Single-Users Only

Single-User − > 6-log reduction of 3 non-enveloped viruses OR

− > 6-log reduction of two gram-positive and two 

gram-negative vegetative bacteria

Tier 3 Bioburden Reduction of N95 

Respirators for Single-Users 

Only to Supplement CDC 

Reuse Recommendations

Single-User Only to 

Supplement 

Existing CDC Reuse 

Recommendations

− > 3-log reduction of non-enveloped virus OR

− > 3-log reduction of two gram-positive and two 

gram-negative vegetative bacteria OR

− other evidence demonstrating similar effect

*Applies to respirators that are non-cellulose and compatible for decontamination
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 Methods for decontamination and bioburden reduction of N95 

respirators

 Evidence of potential effectiveness

 Recommendations/Observations and common challenges in 

Emergency Use Authorization (EUA) request submissions

Decontaminating Respirators for Health Care 

Personnel Use during the COVID-19 Pandemic
8

Questions?

CDRH-COVID19-SurgicalMasks@fda.hhs.gov

Slide Presentation, Transcript and Webinar Recording 

will be available at:

https://www.fda.gov/training/cdrhlearn

Under Heading: Specialty Technical Topics and Subheading

Personal Protective Equipment (PPE)

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