Zdrowie i gospodarka · 26/04/2019

FDA Releases Final Guidance on Characterization of UHMWPE Used in Orthopedic Devices

The Food and Drug Administration (FDA) has released a final guidance document outlining the characterization of ultrahigh molecular weight polyethylene (UHMWPE) used in orthopedic devices, providing recommendations for industry and FDA staff on the types of UHMWPE commonly used and the required information and testing for premarket submissions.