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Transitioning from the Use of 

Non-NIOSH-Approved Respirators

Office of Strategic Partnerships and Technology Innovation (OST) 

Center for Devices and Radiological Health (CDRH) 

U.S. Food and Drug Administration (FDA) 

June 8, 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 May 27, 2021, the FDA issued a letter to health care personnel and facilities 

recommending they transition away from crisis capacity conservation 

strategies, such as using non - NIOSH - approved disposable respirators including 

non-NIOSH-approved imported respirators such as KN95s. 

• This recommendation is in follow - up to the April 9, 2021, letter in which the FDA

recommended a transition away from decontamination or bioburden - reduction 

systems for cleaning and disinfecting disposable respirators, which were being 

reused by health care personnel 

• 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) and consistent with CDC’s updated 

recommendations, the FDA believes health care personnel and facilities can 

transition away from using non - NIOSH - approved respirators and from utilizing 

decontamination and bioburden reduction systems. These crisis capacity 

conservation strategies have been used to address respirator shortages during the 

COVID - 19 outbreak. 
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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 use of all non-NIOSH-approved respirators, including imported non-NIOSHapproved respirators, to only when there are insufficient supplies of new NIOSH - approved 

filtering facepiece respirators (FFRs), or when any new respirators are unavailable.

– 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 when any new respirators are unavailable. 

– Transition away from a crisis capacity strategy for respirators, such as use of nonNIOSH - approved respirators and 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 air - purifying respirators 

(PAPRs). Even if health care personnel and facilities are unable to obtain the respirator model 

that they would prefer, the FDA recommends obtaining and using a new NIOSH - approved 

respirator before using a non-NIOSH-approved respirator or decontaminating or bioburdenreducing 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 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

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www.fda.gov/training/cdrhlearn

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Sub - heading Personal Protective Equipment (PPE) 

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