The FDA welcomed comments on the draft guidance titled, “Technical Considerations for Additive Manufactured Devices” which was published May 2016. The deadline for submission was August 8, 2016. Among many individual submissions, were several companies that took advantage of the opportunity.
- Advanced Medical Technology Association (AdvaMed)
- Johnson & Johnson
- Stryker Corporation
- American Orthotic & Prosthetic Association (AOPA)
- Novartis Pharmaceuticals
- 510(k) Coalition
- Zimmer Biomet
All 28 comments may be found HERE.