Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators; Draft Guidance for Industry and Food and Drug Administration Staff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 International Safety Equipment Association (ISEA), representing the PPE and safety equipment industry, supports the FDA's effort to reduce duplicative regulatory requirements for NIOSH-approved respirators. However, they request specific clarifications regarding the withdrawal of FDA oversight, the continuation of specific testing requirements (like fluid and flame resistance), and the availability of export documentation.

The commenter supports the broad acceptance of NIOSH-approved respirators in healthcare settings, arguing that NIOSH approval is a sufficient benchmark for worker protection and that dual regulation with the FDA creates unnecessary complexity. They urge the FDA to clarify the distinction between occupational respiratory protection claims and patient-facing medical claims to streamline regulatory pathways and improve supply-chain resilience.

Stryker Instruments, a medical device company, supports the draft guidance while providing specific technical feedback to ensure clarity and effective implementation. They advocate for the inclusion of certain respirator types (like N99 FFRs) in the scope and suggest modifications to the policy regarding fluid repellency and sterile labeling.

The Johns Hopkins Center for Health Security supports the FDA's proposal to simplify the regulatory approval process for certain respirators. They argue that the current involvement of the FDA adds unnecessary delays and confusion, suggesting that NIOSH should be the sole regulatory agency responsible for respirator approvals.

LifeProtect LLC, a U.S.-based holding company and manufacturer of personal protective equipment, supports the FDA's efforts to modernize and streamline the regulatory framework for NIOSH-approved respirators. They argue that while the draft guidance is a positive step, the FDA should provide greater clarity and harmonization regarding which agency (specifically suggesting OSHA) should oversee reusability and workplace-use claims for advanced antimicrobial respirators.

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.

Mitchell Berger, writing in a private capacity, provides several specific suggestions to improve the draft guidance, including clarifying the intended audience and the distinction between medical and occupational uses. He also advocates for increased coordination between the FDA, NIOSH, and OSHA, and suggests moving toward a unified, performance-based regulatory framework for respirators.