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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 055 Date of Entry 12/21/2020 
FR Recognition Number 8-547
Standard
ASTM F629-20
Standard Practice for Radiography of Cast Metallic Surgical Implants
Scope/Abstract
1.1 This practice covers the procedure for radiographic testing of cast metallic surgical implants and related weldments.
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FDA recognition of ASTM F629-15 [Rec# 8-421] will be superseded by recognition of ASTM F629-20 [Rec# 8-547]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-421] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 8-421] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Implantable medical devices
FDA Technical Contacts
 David M. Saylor
  FDA/OC/CDRH/OSEL/DBCMS/
  301-796-2626
  david.saylor@fda.hhs.gov
 Matthew Di Prima
  FDA/OC/CDRH/OSEL/DAM/
  301-796-2507
  matthew.diprima@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Materials
*These are provided as examples and others may be applicable.
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