Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Ai
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators." This draft guidance document provides a proposed compliance policy for and information about
| Agency | Health and Human Services Department, Food and Drug Administration |
|---|---|
| Document type | Notice |
| Published | 2026-04-20 |
| Summary | The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators." This draft guidance document provides a proposed compliance policy for and information about respirators approved by the Centers for Disease Control and Prevention (CDC) National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 respir |
| Document number | 2026-07613 |
| Official record | https://www.federalregister.gov/documents/2026/04/20/2026-07613/compliance-policy-regarding-premarket-and-other-requirements-for-certain-niosh-approved |