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# No Enforcement for Reusing Certain Respirators
- URL: https://www.fdaweb.com/no-enforcement-for-reusing-certain-respirators/
- Published: 2020-11-25T12:00:00.000Z
- Updated: 2026-09-14T16:38:00.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148173

FDA has issued an immediately-in-effect guidance, *Enforcement Policy for Bioburden Reduction Systems Using Dry Heat to Support Single-User Reuse of Certain Filtering Facepiece Respirators During the Coronavirus 2019 (Covid-19) Public Health Emergency*, saying that the agency does not intend to object to using dry heat systems to reduce bioburden and support single-user reuse of compatible filtering facepiece respirators (FFRs) when existing Centers for Disease Control reuse recommendations are followed. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-bioburden-reduction-systems-using-dry-heat-support-single-user-reuse-certain?utm%5Fmedium=email&utm%5Fsource=govdelivery) says the agency believes that the use of dry heat systems as a bioburden reduction method to support single-use reuse of compatible respirators will not create an undue risk where the critical cycle parameters and labeling elements in the guidance are met.

The 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 or **(2)** have been authorized under the EUA for non-NIOSH approved FFRs that are not manufactured in China or **(3)** are FDA-cleared as intended for use by healthcare personnel.

“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 by healthcare professionals for the duration of the Covid-19 public health emergency,” FDA says.