FDA guidance covers classification for ultrahigh molecular weight polyethylene orthopedic devices

Laura Dyrda -   Print  |

The FDA released final guidance on classifying orthopedic devices that include ultrahigh molecular weight polyethylene, according to Regulatory Focus, a publication of the Regulatory Affairs Professional Society.


The classifications cover orthopedic devices with UHMWPE types, including conventional, highly cross linked, highly crosslinked material with antioxidants and nonconventional UHMWPE.

Final guidance includes multiple changes from the draft guidance issued in 2016, including shelf life testing recommendations and the information to include about packaging when submitting the device to the FDA.

"We recommend devices undergo real-time aging to determine definitively the effects of aging on the maintenance of sterility and device performance. If you use devices subjected to accelerated aging, we recommend that you specify the way in which the device was aged and develop a rationale to explain how the result of the shelf life testing based on accelerated aging are representative if the results of the device were aged in real time," states the guidance.

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