A document finalizing guidance on the characterization of ultrahigh-molecular-weight polyethylene (UHMWPE) used in orthopedic devices was issued today, April 26, by FDA. It updates a draft document inviting comments that was published on Feb. 12, 2016; the final guidance features a number of changes made in response to suggestions from industry and other stakeholders.
The guidance addresses the characterization and testing of UHMWPE materials used in orthopedic devices, writes FDA in the introduction. It is intended to assist manufacturers in determining the appropriate information and testing to submit for premarket notifications, aka 510(k)s; de novo requests; premarket approval applications; humanitarian device exemptions; and investigational device exemptions.
Among changes in the guidance document compared with the draft version is the inclusion of ASTM F2759 and ASTM F2565 standards and expanded recommendations for shelf-life testing and instructions on packaging information that should be included in a submission, according to an article on the Regulatory Affairs Professionals Society (RAPS) website.
FDA organizes UHMWPE materials used in orthopedic devices into four general categories: Conventional UHMWPE; highly crosslinked UHMWPE; antioxidant highly crosslinked UHMWPE; and non-conventional UHMWPE. The latter category encompasses PE materials that do not fit into the other three categories, including lower molecular weight PEs, functionalized UHMWPE, porous PEs and materials with modified surfaces.
The guidance document is available on the FDA website.
The global market for UHMWPE is expected to grow at a compound annual growth rate of roughly 10.5% over the next five years, according to a report from Global Info Research (Hong Kong). It will reach $76 million in 2024, up from $42 million in 2019.