| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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058
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Date of Entry 05/30/2022
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FR Recognition Number
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8-586
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| Standard | |
ASTM F2989-21
Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications |
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Scope/Abstract1.1 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. |
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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| FDA recognition of ASTM F2989-13 [Rec# 8-362] will be superseded by recognition of ASTM F2989-21 [Rec# 8-586].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. |
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Public Law, CFR Citation(s) and Procode(s)*
| Implantable Medical Devices |
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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. |
