Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators: Draft Guidance for Industry and Food and Drug Administration Staff

Issue Date: April 20, 2026
Issued by: Center for Devices and Radiological Health
Topic(s):
Status: Draft

Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators: Draft Guidance for Industry and Food and Drug Administration Staff

FDA is issuing this draft guidance to provide a proposed compliance policy for and information about respirators approved by the Centers for Disease Control and Prevention (CDC) National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.

Download the Guidance Document