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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 063 Date of Entry 10/07/2024 
FR Recognition Number 1-180
Standard
NFPA  99:2024
Health Care Facilities Code
Scope/Abstract
NFPA 99, Health Care Facilities Code, offers the latest performance criteria for health care facilities and appliances, including medical gas and vacuum systems, electrical systems, gas equipment, and features of fire protection.

The code features provisions for the installation, inspection, maintenance, and testing of all health care facilities-including hospitals, nursing homes, and limited care settings.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of NFPA 99:2021 [Rec# 1-153] will be superseded by recognition of NFPA 99:2024 [Rec# 1-180]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-153] until December 26, 2026. After this transition period, declarations of conformity to [Rec# 1-153] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§868.5470 Chamber, Hyperbaric Class 2 CBF
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Annie Abraham
  FDA/OMPT/CDRH/OPEQ/OHTI/DHTIC/
  240-402-5219
  Annie.Abraham@fda.hhs.gov
Standards Development Organization
NFPA National Fire Protection Association http://www.nfpa.org/
FDA Specialty Task Group (STG)
Anesthesiology
*These are provided as examples and others may be applicable.
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