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# 3 Companies Like AdvaMed Comments on Draft Guidance
- URL: https://www.fdaweb.com/3-companies-like-advamed-comments-on-draft-guidance/
- Published: 2016-05-17T12:00:00.000Z
- Updated: 2026-09-14T21:03:24.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135695

Zimmer Biomet, Stryker, and Johnson & Johnson all say they agree with [comments](https://www.fdaweb.com/approve-orthopedic-device-guidance-asap-advamed/) submitted by AdvaMed on an FDA draft guidance on characterization of ultrahigh molecular weight polyethylene (UHMWPE) used in orthopedic devices. Stryker [says](https://www.regulations.gov/?ref=fdaweb.com#!documentDetail;D=FDA-2016-D-0363-0011) that as in the AdvaMed comments, it also recommends that the agency finalize the guidance as soon as possible and revise it to reference two ASTM standards.

Zimmer Biomet also [calls](https://www.regulations.gov/?ref=fdaweb.com#!documentDetail;D=FDA-2016-D-0363-0010) for referencing the two ASTM standards and says that FDA should ensure that its draft guidance and the two standards, which were recently recognized by the agency, are aligned and consistent.

In addition to associating itself with the AdvaMed comments, Johnson & Johnson [says](https://www.regulations.gov/?ref=fdaweb.com#!documentDetail;D=FDA-2016-D-0363-0012) that it is important to focus on these key issues: clarifying the definition of conventional UHMWPE, correcting references to antioxidant containing UHMWPE, clarifying the types of polyethylene used in implants, correcting the reference to annealing, correcting the discussion of shelf life and stability, and clarifying that ASTM F648 applies only to conventional UHMWPE.