Draft Compliance Policy for NIOSH-Approved Respirators Under 21 CFR 878.4040 and 880.6260
Summary
FDA's Center for Devices and Radiological Health (CDRH) has issued draft guidance establishing a proposed compliance policy for respirators approved by CDC NIOSH under 42 CFR part 84. The draft applies to surgical N95 respirators and other NIOSH-approved air-purifying respirators, including PAPRs, non-powered FFRs, elastomeric respirators, and FFRs for general public use in public health emergencies. FDA seeks public comments on the compliance policy by June 19, 2026.
What changed
FDA has released draft guidance establishing a proposed compliance policy for NIOSH-approved respirators regulated as medical devices. The guidance covers three categories: surgical N95 respirators and N95 FFRs (21 CFR 878.4040), other NIOSH-approved non-surgical respirators including PAPRs and elastomeric respirators, and FFRs for general public use in public health emergencies (21 CFR 880.6260).
Medical device manufacturers producing NIOSH-approved respirators, as well as healthcare providers utilizing these devices in clinical settings, should review the proposed compliance policy and submit comments via regulations.gov or written submission to Dockets Management before the June 19, 2026 deadline. Affected parties should monitor FDA's docket FDA-2025-D-7121 for updates as CDRH works toward finalizing this guidance.
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Apr 18, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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06/19/2026
Submit Comments Online Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2025-D-7121
Docket Number: FDA-2025-D-7121 Issued by: Guidance Issuing Office Center for Devices and Radiological Health FDA is issuing this draft guidance to provide a proposed compliance policy for and information about respirators approved by the Centers for Disease Control and Prevention (CDC) National Institute for Occupational Safety and Health (NIOSH) in accordance with 42 CFR part 84, specifically: surgical N95 respirators and N95 filtering facepiece respirators (FFRs) classified under 21 CFR 878.4040; other NIOSH approved, non-surgical respirators including powered air-purifying respirators (PAPRs), non-powered, air-purifying particulate FFRs, and reusable respirators (e.g., elastomeric half and full facepiece respirators); and FFRs for use by the general public in public health medical emergencies classified under 21 CFR 880.6260.
- ## Content current as of:
04/17/2026
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