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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 056 Date of Entry 06/07/2021 
FR Recognition Number 8-562
Standard
ISO ASTM 52904 First edition 2019-08
Additive manufacturing - Process characteristics and performance - Practice for metal powder bed fusion process to meet critical applications
Scope/Abstract
This practice describes the operation and production control of metal powder bed fusion (PBF) machines and processes to meet critical applications such as commercial aerospace components and medical implants. The requirements contained herein are applicable for production components and mechanical test specimens using powder bed fusion (PBF) with both laser and electron beams.
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FDA recognition of ASTM F3303-18 [Rec# 8-490] will be superseded by recognition of ISO/ASTM 52904 First edition 2019-08 [Rec# 8-562]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-490] until July 10, 2022. After this transition period, declarations of conformity to [Rec# 8-490] will not be accepted.
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff: Technical Considerations for Additive Manufactured Medical Devices, Issued December 2017.
FDA Technical Contact
 Matthew Di Prima
  FDA/OC/CDRH/OSEL/DAM/
  301-796-2507
  matthew.diprima@fda.hhs.gov
Standards Development Organizations
ISO International Organization for Standardization https://www.iso.org/
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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