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# AdvaMed Comments on FDA 3D Printing Paper
- URL: https://www.fdaweb.com/advamed-comments-on-fda-3d-printing-paper/
- Published: 2022-02-09T12:00:00.000Z
- Updated: 2026-09-14T17:31:58.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151126

AdvaMed says an FDA discussion paper on 3D printing of medical devices at the point of care needs to include a “firm statement … that 3D printing of repair parts or remanufactured devices should fall within the auspices of this guidance.” The association comment [letter](https://downloads.regulations.gov/FDA-2021-N-1272-0032/attachment%5F1.pdf?ref=fdaweb.com) says AdvaMed agrees with the FDA guiding principle in the discussion paper that the regulatory approach should be risk-based. And it says it concurs that device specification should not change based on the location of manufacture.

The letter provides AdvaMed responses to questions FDA posed in the discussion paper.