FDA Finalizes Guidance on UHMWPE in Orthopedic Devices
The US Food and Drug Administration (FDA) on Thursday finalized guidance on the use of various types of ultrahigh molecular weight polyethylene (UHMWPE) in orthopedic devices.The 18-page guidance finalizes a draft version released for comment in 2016 and provides recommendations for characterizing and testing Class II and III orthopedic devices that contain UHMWPE materials for various types of submissions including premarket notifications (510(k)), de novo requests, premarket approval (PMA) applications, humanitarian device exemptions (HDE) and investigational device exemptions (IDE).
Within the guidance, FDA describes the characteristics of four types of UHMWPE, including conventional UHMWPE, highly crosslinked UHMWPE, highly crosslinked UHMWPE containing antioxidants and nonconventional UHMWPE and what information is recommended to be included in submissions for each type of material.
The final guidance makes several changes from the draft version in response to comments received during the public consultation, including the addition of references to two ASTM standards requested by AdvaMed: ASTM F2759 and ASTM F2565.
In another change, the final guidance now refers to one of the types of UHMWPE as antioxidant highly crosslinked UHMWPE as opposed to vitamin E highly crosslinked UHMWPE (VEPE) as it was called in the draft version.
The final guidance also expands the section discussing shelf life to include recommendations for shelf-life testing and instructions for what information to include regarding packaging in a submission.
Additionally, two of the appendices, one listing applicable federal regulations and another listing the information to include in test reporting, have been removed and a new appendix listing applicable FDA-recognized consensus standards has been added.
FDA, Federal Register Notice