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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 034 Date of Entry 01/30/2014 
FR Recognition Number 8-362
Standard
ASTM F2989-13
Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications
Scope/Abstract
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for three grades of metal injection molded (MIM) unalloyed titanium components in two types to be used in the manufacture of surgical implants.

1.2 The Type 1 MIM components covered by this specification may have been densified beyond their as-sintered density by post-sinter processing.
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FDA recognition of ASTM F2989-13 [Rec# 8-362] will be superseded by recognition of ASTM F2989-21 [Rec# 8-586]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-362] until July 9, 2023. After this transition period, declarations of conformity to [Rec# 8-362] will not be accepted.
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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