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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 065 Date of Entry 12/22/2025 
FR Recognition Number 8-635
Standard
ASTM  F75-23
Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
Scope/Abstract
This specification covers the requirements for unfinished cobalt-28chromium-6molybdenum (UNS R30075) investment product alloy castings for surgical implant applications, and casting alloys of the same in the form of shot, bar, or ingots to be used in the manufacture of surgical implants. This specification does not apply to completed surgical implants made from castings. Both product castings and casting alloys shall conform to specified chemical composition and mechanical requirements including ultimate tensile strength, yield strength, elongation, and reduction of area. Product castings shall additional undergo liquid penetrant, radiographic, metallographic, and hardness examination.
Extent of Recognition
Complete standard
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.
Transition Period
FDA recognition of ASTM F75-18 [Rec# 8-498] will be superseded by recognition of ASTM F75-23 [Rec# 8-635]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-498] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 8-498] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Implantable Medical Devices
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.
FDA Technical Contacts
 David M. Saylor
  FDA/OC/CDRH/OSEL/DBCMS/
  301-796-2626
  david.saylor@fda.hhs.gov
 Matthew Di Prima
  FDA/OC/CDRH/OSEL/DAM/
  301-796-2507
  matthew.diprima@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Materials
*These are provided as examples and others may be applicable.
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