CDRH Industry: Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices - Draft Guidance for Industry and FDA Staff

A draft guidance has been posted titled, "Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices."  This guidance addresses the characterization and testing of orthopedic devices that use UHMWPE materials such as conventional UHMWPE, highly crosslinked UHMWPE, and highly crosslinked UHMWPE containing vitamin E. This document outlines the information we recommend you include in a submission to FDA to characterize the UHMWPE material (e.g., material description, sterility, biocompatibility, mechanical properties, and chemical properties).