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Enforcement Policy for Bioburden Reduction 

Systems Using Dry Heat to Support Single-User 

Reuse of Certain Filtering Facepiece 

Respirators during the COVID-19 Pandemic

Office of Health Technology 4: Surgical and Infection Control Devices

Office of Product Evaluation and Quality (OPEQ)

Center for Devices and Radiological Health (CDRH)
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To help address the urgent public health concerns caused by personal protective 

equipment (PPE) shortages, the FDA does not intend to object to the use of dry 

heat systems to reduce bioburden and support single-user reuse of compatible 

filtering facepiece respirators (FFRs) without marketing authorization when 

existing Centers for Disease Control and Prevention (CDC) reuse 

recommendations are followed, where such devices do not create an undue risk 

in light of the public health emergency.

Enforcement Policy
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• Bioburden reduction systems are those which could achieve

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

o > 3-log reduction of two gram-positive and two gram-negative vegetative 

bacteria

• These systems are to be used only to supplement CDC reuse recommendations 

(such as, ≤ 5 donnings, storing respirator for 5 days in a paper bag, etc.)

• For more information on decontamination and bioburden reduction, please refer 

to:

o 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

Bioburden Reduction Systems
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• FFRs that:

o do not have exhalation valves, and

o do not incorporate a duck-bill design, and 

o do not contain antimicrobial/antiviral agents

and

 have been authorized under the emergency use authorization (EUA) for 

NIOSH-approved FFRs, or 

 have been authorized under the EUA for non-NIOSH-approved FFRs that are 

not manufactured in China, or 

 are FDA-cleared as intended for use by healthcare personnel (HCP)

(“compatible respirators” or “compatible FFRs”) 

Filtering Facepiece Respirators (FFRs)

within the Scope of the Policy
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• Consistent exposure of 70°C for 60 minutes or 75°C for 30 minutes

• Note:

o Chamber temperature should be monitored closely and recorded throughout 

the cycle to confirm accurate and even distribution of heat; 

o The system should have highly controlled convective heat transfer (for 

example, laboratory oven, industrial convection oven) to avoid the risk of 

localized over-temperature; and 

o Household appliances (for example, home ovens, pressure cookers, 

multicookers) should not be used due to the lack of accuracy and precision in 

temperature control and the risks of cross-contamination from mixed use. 

Critical Cycle Parameters for Dry Heat
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• Necessary labeling should be provided to convey important information to help 

users better understand the device either by: 

o a manufacturer if manufacturing ovens for bioburden reduction of FFRs or 

o a healthcare organization that is repurposing ovens for bioburden reduction. 

• For example, the following information should be included:

o What is bioburden reduction?

o What are critical cycle parameters?

o What are the compatible FFRs?

o “Only to be used to supplement CDC’s reuse recommendations of FFRs”

Labeling – Bioburden Reduction System
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• Handling instructions include:

o Instructions for the handling of both contaminated and bioburden-reduced 

compatible FFRs should be provided by the healthcare organization to 

personnel managing the process

o A description of chain of custody and safeguards (for example, ensuring that 

personnel involved in use of the dry heat system utilize appropriate personal 

protective equipment (PPE)) to prevent inadvertent personnel exposure to 

contaminated FFRs and eliminate potential cross-contamination between FFRs 

(for example, individual packaging and labeling for respirators)

Labeling – Handling Instructions
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• Healthcare organizations should provide labeling of the compatible FFRs that have been 

bioburden-reduced using dry heat to inform healthcare personnel (HCP) of proper 

procedures and precautions for using bioburden-reduced FFRs as described in the 

guidance. For example:

o Healthcare personnel should follow CDC’s recommendations, as appropriate

o Bioburden reduced FFRs are only to be reused by single user

o Respirators that have been bioburden-reduced are no longer considered NIOSHapproved unless the NIOSH-approval holder confirms otherwise, and their performance 

(that is, fit, filtration, and breathability) might not meet NIOSH-approved N95 standards; 

in accordance with CDC recommendations, users should perform visual and tactile 

inspection of the respirator to verify no loss of respirator fit or function and should 

perform seal checks

o When to discard respirators

o Report Adverse events to FDA MedWatch by submitting the FDA Form 3500 or by 

calling 1-800-FDA-1088.

Labeling – Bioburden Reduced FFR
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• Enforcement Policy for Bioburden Reduction Systems Using Dry Heat to Support 

Single-User Reuse of Certain Filtering Facepiece Respirators During the COVID-19 

Public Health Emergency Guidance

• 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

• Implementing Filtering Facepiece Respirator (FFR) Reuse, Including Reuse after 

Decontamination, When There Are Known Shortages of N95 Respirators 

• Recommended Guidance for Extended Use and Limited Reuse of N95 Filtering 

Facepiece Respirators in Healthcare Settings

Resources
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Questions?

Email: 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 Sub-heading

Personal Protective Equipment (PPE)

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