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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 055 Date of Entry 12/21/2020 
FR Recognition Number 8-537
Standard
ASTM F620-20
Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
Scope/Abstract
1.1 This specification covers the requirements for titanium alloy forgings for surgical implants, in the alpha plus beta condition, when the material forged conforms to Specifications F136 (UNS R56401), F1295 (UNS R56700), F1472 (UNS R56400), or F2066 (UNS R58150).
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FDA recognition of ASTM F620-11 (Reapproved 2015) [Rec# 8-217] will be superseded by recognition of ASTM F620-20 [Rec# 8-537]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-217] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 8-217] 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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