2026-07613: Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators." This draft guidance document provides a proposed compliance policy for and information about respirators approved by the Centers for Disease Control and Prevention (CDC) National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. These devices are collectively referred to in the guidance and this notice as "certain FFRs and reusable respirators." This guidance, once finalized, is intended to facilitate more efficient and effective use of resources, consistent with the least burdensome policies for devices. This draft guidance is not final nor is it for implementation at this time.

The agency’s own summary, as published.