Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators; Draft Guidance for Industry and Food and Drug Administration Staff

The commenter supports the guidance's intent to streamline regulatory requirements for NIOSH-approved respirators but urges the FDA to consider real-world occupational challenges like heat stress and physical exertion. They also suggest providing more specific guidance on training and maintenance for smaller employers to ensure that regulatory flexibility does not compromise worker safety.