| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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061
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Date of Entry 12/18/2023
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|
FR Recognition Number
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8-610
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| Standard | |
ASTM F601-23
Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants |
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Scope/Abstract| 1.1 This practice is intended as a standard for fluorescent penetrant inspection of metallic surgical implants. |
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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| FDA recognition of ASTM F601-18 [Rec# 8-483] will be superseded by recognition of ASTM F601-23 [Rec# 8-610]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-483] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 8-483] 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. |
