| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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031
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Date of Entry 08/06/2013
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FR Recognition Number
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8-342
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| Standard | |
ASTM F1537-11
Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) |
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Scope/Abstract| 1.1 This specification covers the chemical, mechanical, and metallurgical requirements for three wrought cobalt-28chromium-6molybdenum alloys used for surgical implants. The properties specified apply specifically to wrought bar, rod, and wire. |
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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FDA recognition of ASTM F1537-11 [Rec# 8-342] will be superseded by recognition of ASTM F1537-20 [Rec# 8-541]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-342] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 8-342] 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. |
