FDA announces draft guidance on compliance policy for certain NIOSH-approved air-purifying respirators; comment period open (FR Doc. 2026-07613)

FDA published a Federal Register notice announcing availability of a draft guidance titled “Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators.” The draft guidance describes FDA’s intended compliance approach for certain respirators approved by NIOSH under 42 CFR Part 84 that may also fall under FDA medical device authorities in specific contexts (e.g., surgical N95s, N95 FFRs, PAPRs, elastomeric respirators). Compliance teams for manufacturers/importers of NIOSH-approved respirators used in healthcare/medical-device contexts should review the draft policy and consider submitting comments by the deadline stated in the notice.