FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

FDA Finalizes Guidance for UHMWPE Orthopedic Devices

April 30, 2019

CDRH released final guidance for sponsors of orthopedic devices containing ultrahigh molecular weight polyethylene (UHMWPE) with advice on information to include in requests and submissions.

The guidance provides sponsors with recommendations for premarket notification submissions, de novo requests, premarket approval (PMA) applications, humanitarian device exemptions (HDEs) and investigational device exemptions (IDEs).

Manufacturers are advised to include information on material processing, shelf-life, biocompatibility and the type of UHMWPE being used.

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