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Home » FDA Advises on How to Demonstrate Biocompatibility for Non-Spinal Devices
FDA Advises on How to Demonstrate Biocompatibility for Non-Spinal Devices
When submitting a 510(k) application for non-spinal bone plates, screws and washers, sponsors may reference “previous testing experience or the literature” to demonstrate biocompatibility, provided the device is identical in composition to the reference product, the FDA said in a draft guidance released Tuesday.