Nonrulemaking

Requests that the FDA issue, via regulation, changes to 21 CFR 868.5470, with proposed language providing that “hyperbaric chambers shall comply with the FDA’s recognized consensus standards for hyperbaric chambers, i.e. NFPA 99, Health Care Facilities Code (2021) and ASME PVHO-1, Safety Standard for Pressure Vessels for Human Occupancy (2019) and update the FDA’s recognized consensus.

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