| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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043
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Date of Entry 06/27/2016
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FR Recognition Number
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8-421
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| Standard | |
ASTM F629-15
Standard Practice for Radiography of Cast Metallic Surgical Implants |
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Scope/Abstract| 1.1 This practice covers the procedure for radiographic testing of cast metallic surgical implants and related weldments. |
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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| FDA recognition of ASTM F629-15 [Rec# 8-421] will be superseded by recognition of ASTM F629-20 [Rec# 8-547].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. |
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Public Law, CFR Citation(s) and Procode(s)*
| 21 CFR 888.3XXX Metallic components of all implantables |
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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 Contacts
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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. |
