FDA publishes final guidance document for UHMWPE in orthopedic devices

Re UHMWPE:

FDA issued a final guidance document on the characteristics of ultra high molecular weight polyethylene (UHMWPE) for orthopedic devices on April 26. It updated a draft document for comment issued on February 12, 2016; the final guidance included some modifications based on industry and other stakeholder recommendations.

FDA writes in the introduction that the guidelines cover the characteristics and testing of UHMWPE materials used in orthopedic machinery. Designed to assist manufacturers in determining appropriate information and tests to submit pre-sales notices, ie 510(k)s; De Novo applications; pre-sales approval procedures; humanitarian equipment tax exemptions; and clinical trial equipment tax exemptions.

According to an article on the Regulatory Affairs Professionals Association (RAP) website, some of the changes in the guidance document include the inclusion of ASTM F2759 and ASTM F2565 standards in the submission, as well as expanded recommendations for shelf life testing. And a description of the packaging information.

FDA classifies UHMW-PE materials used in orthopedics into four categories: conventional UHMWPE; highly crosslinked UHMWPE; antioxidant highly crosslinked UHMWPE; and unconventional UHMWPE. The latter contains PE materials that do not fall into the other three categories, including low molecular weight PE, functionalized UHMW-PE, porous PE, and modified surface materials.

According to a report by Global Information Research (Hong Kong), UHMWPE’s global market is expected to grow at a compound annual growth rate of approximately 10.5% over the next five years. It will reach $76 million in 2024, up from $42 million in 2019.