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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 063 Date of Entry 12/23/2024 
FR Recognition Number 8-627
Standard
ASTM  F3604-23
Standard Practice for Validating the Additive Manufacturing (AM) Production Process for Medical Devices Produced Using Laser Powder Bed Fusion.
Scope/Abstract
1.1 This practice provides an overview of how to perform process validation for medical devices manufactured using PBF/LB/M. The topics that will be covered include machine qualifications, software used in the manufacturing process, the importance of design specification and verification on process validation, and raw materials.

1.2 This practice also provides recommendations for process characterization, risk management, additive manufacturing (AM) facility qualification, and process control as a prerequisite for qualification activity, including installation qualification/operational qualification/performance qualification (IQ/OQ/PQ).

1.3 The practice is primarily focused on non-device-specific AM system(s) validation. Additional information may be needed in reference to the performance of the actual device.
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.
Public Law, CFR Citation(s) and Procode(s)*
Cross cutting
Relevant FDA Guidance and/or Supportive Publications*
1. Technical Considerations for Additive Manufactured Medical Devices-Guidance for Industry and Food and Drug Administration Staff, issued December 2017.

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 Contact
 David Hwang
  CDRH/OPEQ/OHTVI/DHTVIB
  --
  david.hwang@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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