Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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043
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Date of Entry 06/27/2016
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FR Recognition Number
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8-431
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Standard | |
ASTM F2971-13 Standard Practice for Reporting Data for Test Specimens Prepared by Additive Manufacturing |
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Scope/Abstract1.1 This practice describes a standard procedure for reporting results by testing or evaluation of specimens produced by additive manufacturing (AM). This practice provides a common format for presenting data for AM specimens, for two purposes: (1) to establish further data reporting requirements, and (2) to provide information for the design of material property databases. |
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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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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. |