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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 055 Date of Entry 12/21/2020 
FR Recognition Number 8-554
Standard
ISO ASTM  TR 52912 First edition 2020-09
Additive manufacturing - Design - Functionally graded additive manufacturing
Scope/Abstract
The use of Additive Manufacturing (AM) enables the fabrication of geometrically complex components by accurately depositing materials in a controlled way. Technological progress in AM hardware, software, as well as the opening of new markets demand for higher flexibility and greater efficiency in today's products, encouraging research into novel materials with functionally graded and high-performance capabilities. This has been termed as Functionally Graded Additive Manufacturing (FGAM), a layer-by-layer fabrication technique that involves gradationally varying the ratio of the material organization within a component to meet an intended function. As research in this field has gained worldwide interest, the interpretations of the FGAM concept requires greater clarification. The objective of this document is to present a conceptual understanding of FGAM. The current-state of art and capabilities of FGAM technology will be reviewed alongside with its challenging technological obstacles and limitations. Here, data exchange formats and some of the recent application is evaluated, followed with recommendations on possible strategies in overcoming barriers and future directions for FGAM to take off.
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.
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Additive Manufactured Medical Devices, 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 Contacts
 Matthew Di Prima
  FDA/OC/CDRH/OSEL/DAM/
  301-796-2507
  matthew.diprima@fda.hhs.gov
 Daniel Porter
  FDA/OC/CDRH/OSEL/DAM/
  240-402-0206
  Daniel.Porter@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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