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Transitioning from the Use of Decontaminated 

Disposable Respirators

Office of Strategic Partnerships and Technology Innovation (OST) 

Center for Devices and Radiological Health (CDRH) 

U.S. Food and Drug Administration (FDA) 

April 27, 2021 
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Agenda

• Overview of FDA Letter to Health Care Personnel & Facilities 

– Background 

– NIOSH - Approved Respirators Authorized under Emergency 

Use Authorization (EUA)

– Recommendations 

– FDA Actions 

• Resources 

• Questions 
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Background

• On April 9, 2021, the FDA issued a letter to health care personnel 

and facilities recommending health care personnel and facilities 

transition away from crisis capacity conservation strategies, 

such as decontaminating or bioburden reducing disposable 

respirators for reuse. 

• Based on the increased domestic supply of new respirators 

approved by the Centers for Disease Control and Prevention’s 

(CDC) National Institute for Occupational Safety and Health 

(NIOSH) currently available to facilitate this transition, the FDA and 

CDC believe there is adequate supply of respirators to transition 

away from use of decontamination and bioburden reduction 

systems. 
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NIOSH-Approved Respirators Authorized under EUA

• During the COVID - 19 public health emergency, NIOSH - approved respirators, 

including N95 respirators, are authorized* on a continual basis under the FDA

emergency use authorization (EUA) for NIOSH - Approved air purifying respirators 

(includes single - use respirators and those designed to be reusable) 

• There are over 6,400 total respirator models or configurations on the NIOSH 

certified equipment list which meet the NIOSH - Approved EUA criteria and thus 

are FDA - authorized, including: 

– Over 600 filtering facepiece respirators (FFR) models (of which there are over 530 N95 

FFR models) 

– Over 5,500 elastomeric respirator configurations, including new elastomeric respirators 

without an exhalation valve 

– Over 360 powered air - purifying respirators (PAPR) configurations 

* until the U.S. Department of Health and Human Services (HHS) Secretary’s declaration that circumstances exist justifying 

authorization is terminated or the EUA is revoked
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Recommendations

• The FDA recommends that health care personnel and facilities: 

– Limit decontamination of disposable respirators. Decontaminated respirators and 

respirators that have undergone bioburden reduction should be used only when there 

are insufficient supplies of new FFRs or if you are unable to obtain any new 

respirators. 

– Transition away from a crisis capacity strategy for respirators, such as 

decontamination of N95 and other FFRs. 

– Increase inventory of available NIOSH-approved respirators— including N95s 

and other FFRs, elastomeric respirators, including new elastomeric respirators 

without an exhalation valve that can be used in the operating room, and powered airpurifying respirators (PAPRs). Even if you are unable to obtain the respirator model 

that you would prefer, the FDA recommends that you obtain and use a new respirator 

before decontaminating or bioburden reducing a preferred disposable respirator. 
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FDA Actions

• The FDA will continue to monitor supply and demand to assess respirator 

availability as facilities systematically transition away from the most extreme 

measures of respirator conservation (that is, crisis capacity strategies) to 

contingency and eventually conventional use.

• Respirators, specifically surgical respirators, presently remain on the FDA’s 

device shortage list. 

• The FDA will continue to keep health care personnel and the public informed 

if new or additional information becomes available. 
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• FDA Recommends Transition from Use of Decontaminated Disposable Respirators - Letter to Health Care 

Personnel and Facilities: 

https://www.fda.gov/medical-devices/letters-health-care-providers/fda-recommends-transition-usedecontaminated-disposable-respirators-letter-health-care-personnel-and

• FDA Considerations for Selecting Respirators for Your Health Care Facility 

https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/considerations-selectingrespirators-your-health-care-facility

• CDC Strategies for Optimizing the Supply of N95 Respirators: 

https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/index.html

• CDC Personal Protective Equipment (PPE) Burn Rate Calculator: 

https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/burn-calculator.html

• OSHA Protecting Workers: Guidance on Mitigating and Preventing the Spread of COVID - 19 in the Workplace: 

https://www.osha.gov/coronavirus/safework

• OSHA enforcement memoranda that include time - limited discretions: 

https://www.osha.gov/coronavirus/standards#temp_enforcement_guidance

Resources
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Questions?

Email: CDRH-COVID19-SurgicalMasks@fda.hhs.gov

Slide Presentation, Transcript, and Webinar Recording 

will be available at: 

www.fda.gov/training/cdrhlearn

Under Heading: Specialty Technical Topics and 

Sub - heading Personal Protective Equipment (PPE) 

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