Federal Register #FDA2025D7121

FDA Draft Guidance on Compliance Policy for NIOSH-Approved Air-Purifying Respirators

This notice announces the FDA's release of a draft guidance on compliance policy for certain NIOSH-approved air-purifying respirators. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - Center for Devices and Radiological Health - Products/Services Covered: - Surgical N95 respirators and N95 filtering facepiece respirators (FFRs) under 21 CFR 878.4040 - Other NIOSH-approved non-surgical respirators, including: - Powered air-purifying respirators (PAPRs) - Non-powered air-purifying particulate FFRs - Reusable respirators (elastomeric half and full facepiece) - FFRs for general public use in public health emergencies (21 CFR 880.6260) - Unique/Notable Requirements: - The guidance is intended to streamline regulatory requirements and facilitate efficient resource use - This is a draft policy, not a procurement or solicitation - No specific OEMs, vendors, products, or quantities are being requested - Public comments are requested to inform the final guidance - No procurement action or contract opportunity is associated with this notice - No product or service line items are listed

Description

The Food and Drug Administration (FDA) has announced the availability of draft guidance concerning compliance policies for certain respirators approved by the CDC's National Institute for Occupational Safety and Health (NIOSH). This guidance covers surgical N95 respirators, other NIOSH-approved non-surgical respirators such as powered air-purifying respirators (PAPRs), and filtering facepiece respirators (FFRs) for public use during health emergencies. The draft aims to streamline regulatory requirements and resource use, and comments are invited by June 22, 2026, to inform the final guidance.

View original listing