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Guidance Issuing OfficeCenter for Devices and Radiological Health
FDA has developed this guidance document for members of industry who submit and FDA staff who review testing of orthopedic devices using ultrahigh molecular weight polyethylene (UHMWPE) material. In this document, the terms “you” and “your” refer to members of industry, also known as sponsors, submitters, or applicants; and the terms “we,” “us,” and “our” refer to FDA. This guidance is intended to assist you in determining the appropriate information and testing to submit in Premarket Notifications (510(k)s), De Novo requests, Premarket Approval (PMA) applications, Humanitarian Device Exemptions (HDEs), and Investigational Device Exemptions (IDEs) for orthopedic devices that contain UHMWPE.
This guidance addresses the characterization and testing of UHMWPE materials used in orthopedic devices. These materials include conventional UHMWPE, highly crosslinked UHMWPE, highly crosslinked UHMWPE containing antioxidants (e.g., α-tocopherol (an isomer of vitamin E)), and non-conventional UHMWPE. This document outlines the information we recommend you include in a submission to FDA to characterize the UHMWPE material (e.g., material description, sterility, biocompatibility, mechanical properties, and chemical properties).
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2016-D-0363.