Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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063
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Date of Entry 10/07/2024
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FR Recognition Number
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1-180
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Standard | |
NFPA 99:2024 Health Care Facilities Code |
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Scope/AbstractNFPA 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. |
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Extent of Recognition
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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. |
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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FDA recognition of NFPA 99:2021 [Rec# 1-153] will be superseded by recognition of NFPA 99:2024 [Rec# 1-180].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. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§868.5470 |
Chamber, Hyperbaric
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Class 2
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CBF
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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. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |