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FDA finalizes guidance on types of UHMWPE used in orthopedic devices
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The FDA announced it finalized guidance issued by the Center for Devices and Radiological Health on numerous types of ultra-high-molecular-weight polyethylene used in orthopedic devices.
The final guidance provides recommendations for the classification and testing of class II and III orthopedic devices that contain ultra-high molecular-weight polyethylene materials for submission, which include premarket notifications, de novo requests, premarket approval applications, humanitarian device exemptions and investigational device exemptions.
Under the guidance, the FDA also offers recommendations to be included in submissions for four types of UHMWPE which include conventional UHMWPE, highly crosslinked UHMWPE, highly crosslinked UHMWPE containing antioxidants and nonconventional UHMWPE. The final guidance also made changes from the draft guidance and added references to two American Society for Testing and Materials (ASTM) standards, ASTM F2759 and ASTM F2565, that were requested by AdvaMed.
In another change, the final guidance now refers to antioxidant highly crosslinked UHMWPE vs. vitamin E highly crosslinked UHMWPE in the draft version. The section on shelf life recommendations was expanded to include shelf-life testing and instructions on what information to include on packaging in a submission. Two appendices on federal regulation and information to include on a test report were removed and replaced with a new appendix which lists applicable consensus standards recognized by the FDA.
Re ference s :
www.fda.gov/media/95791/download