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# Guidance on Polyethylene in Orthopedic Devices
- URL: https://www.fdaweb.com/guidance-on-polyethylene-in-orthopedic-devices/
- Published: 2016-02-12T12:00:00.000Z
- Updated: 2026-09-15T02:35:22.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5134757

*Federal Register* Notice: FDA is making available a draft guidance entitled *Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices*. The guidance identifies the types of UHMWPE currently in use in orthopedic implants, as well as the recommended information and testing that should be included in premarket submissions for such devices. To download this guidance, click [here](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM485862?ref=fdaweb.com). To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-02-12/pdf/2016-02879.pdf?ref=fdaweb.com)