| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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060
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Date of Entry 05/29/2023
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FR Recognition Number
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8-599
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| Standard | |
ASTM F1295-22
Standard Specification for Wrought Titanium-6 Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700) |
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Scope/Abstract| 1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed, cold-worked, or hot-worked titanium-6aluminum-7niobium alloy bar, wire, sheet, strip, and plate to be used in the manufacture of 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| FDA recognition of ASTM F1295-16 [Rec# 8-453] will be superseded by recognition of ASTM F1295-22 [Rec# 8-599]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-453] until July 5, 2026. After this transition period, declarations of conformity to [Rec# 8-453] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Implantable Medical Devices |
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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. |
