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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 034 Date of Entry 01/30/2014 
FR Recognition Number 1-97
Standard
CGA  V-7.1:2011
Standard Method of Determining Cylinder Valve Outlet Connections for Medical Gases
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FDA recognition of CGA V-7.1:2011 [Rec# 1-97] will be superseded by recognition of CGA V-7.1:2021 [Rec# 1-168]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-97] until July 5, 2026. After this transition period, declarations of conformity to [Rec# 1-97] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§868.2700 Regulator, Pressure, Gas Cylinder Class 1 CAN
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
 Benjamin Sommerkorn
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC
  --
  Benjamin.Sommerkorn@fda.hhs.gov
Standards Development Organization
CGA Compressed Gas Associated, Incorporated https://www.cganet.com/
FDA Specialty Task Group (STG)
Anesthesiology
*These are provided as examples and others may be applicable.
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