| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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053
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Date of Entry 12/23/2019
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FR Recognition Number
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8-507
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| Standard | |
ASTM F688-19
Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035) |
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Scope/Abstract| 1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought cobalt-35nickel-20chromium-10molybdenum alloy (UNS R30035) in the form of plate, sheet, and foil 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| FDA recognition of ASTM F688-19 [Rec# 8-507] will be superseded by recognition of ASTM F688-25 [Rec# 8-636]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-507] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 8-507] will not be accepted. |
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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. |
