FDA issues final guidance on characterization of ultrahigh molecular weight polyethylene used in orthopedic devices

Today, the U.S. Food and Drug Administration (FDA) issued the final guidance,Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices. This guidance provides recommendations to industry on how to characterize and test UHMWPE material in orthopedic devices in support of a premarket submission.

The recommendations in the final guidance apply to class II and class III orthopedic devices that contain UHMWPE and that may be submitted for premarket review through Premarket Notifications (510(k)s), De Novo requests, Premarket Approval applications (PMAs), Humanitarian Device Exemptions (HDEs), and Investigational Device Exemptions (IDEs).

The FDA believes the recommendations in this guidance align with current practices and standards that many manufacturers already use for characterizing and testing UHMWPE materials commonly found in orthopedic devices.

Read the Final Guidance

Questions

If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health at 1-800-638-2041, 301-796-7100 or at DICE@fda.hhs.gov.

U.S. Food and Drug Administration

Center for Devices and Radiological Health