Draft FDA Guidance for Characterization of UHMWPE
FDA has developed this draft guidance document for members of industry who submit and FDA staff who review testing of orthopedic devices using ultrahigh molecular weight polyethylene (UHMWPE) material. In this document, the terms “you” and “your” refer to members of industry, also known as sponsors, submitters, or applicants; and the terms “we,” “us,” and “our” refer to FDA. This guidance is intended to assist you in determining the appropriate information and testing to submit in premarket notifications (510(k)s), de novo requests, premarket approval (PMA) applications, humanitarian device exemptions (HDEs), and investigational device exemptions (IDEs) for orthopedic devices that contain UHMWPE. 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).
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