• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 056 Date of Entry 06/07/2021 
FR Recognition Number 8-561
ISO ASTM 52950 First edition 2021-01
Additive manufacturing - General principles - Overview of data processing
This document covers the principal considerations which apply to data exchange for additive manufacturing. It specifies terms and definitions which enable information to be exchanged describing geometries or parts such that they can be additively manufactured. The data exchange method outlines file type, data enclosed formatting of such data and what this can be used for.

This document
- enables a suitable format for data exchange to be specified,
- describes the existing developments for additive manufacturing of 3D geometries,
- outlines existing file formats used as part of the existing developments, and
- enables understanding of necessary features for data exchange, for adopters of this document.

This document is aimed at users and producers of additive manufacturing processes and associated software systems. It applies wherever additive processes are used, and to the following fields in particular:
- producers of additive manufacturing systems and equipment including software;
- software engineers involved in CAD/CAE systems;
- reverse engineering systems developers;
- test bodies wishing to compare requested and actual geometries.
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FDA recognition of ISO 17296-4 First edition 2014-09-01 [Rec# 8-445] will be superseded by recognition of ISO/ASTM 52950 First edition 2021-01 [Rec# 8-561]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-445] until July 10, 2022. After this transition period, declarations of conformity to [Rec# 8-445] 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
Standards Development Organizations
ISO International Organization for Standardization https://www.iso.org/
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.