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# Approve Orthopedic Device Guidance ASAP: AdvaMed
- URL: https://www.fdaweb.com/approve-orthopedic-device-guidance-asap-advamed/
- Published: 2016-05-12T12:00:00.000Z
- Updated: 2026-09-14T21:02:20.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135653

AdvaMed says that given the many substantive requirements in a new FDA draft guidance on characterization of ultrahigh molecular weight polyethylene used in orthopedic devices, as well as in the existing draft guidance that the new one replaces, it will be important for the agency to finalize the latest draft as soon as possible. In a 5/11 [comment](https://www.regulations.gov/contentStreamer?documentId=FDA-2016-D-0363-0009&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com) on the draft, AdvaMed also recommends that FDA reference two ASTM standards in the final guidance and says that the agency should participate in the ASTM process to update one of the standards, particularly as it relates to the addition of alternative antioxidant polyethylene materials. The letter also contains specific line-by-line comments.