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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 057 Date of Entry 12/20/2021 
FR Recognition Number 8-570
Standard
ASTM  F1108-21
Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
Scope/Abstract
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for cast titanium-6aluminum-4vanadium alloy (UNS R56406).
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.
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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