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biocompatibility, provided the device is identical in composition to the reference product, the FDA said in a draft guidance released Tuesday.

The agency recommended a side-by-side comparison of the submitted device and the predicate device, with an explanation of how any differences — such as the shape or surface properties — will not impact the safety and efficacy of the submitted item.

The guidance includes several tables with examples of the information needed for 510(k) submissions, including device descriptions, predicate comparisons and examples of test methods.

The draft document also considers sterility, magnetic resonance compatibility for passive implants, mechanical performance, labeling, reprocessing, pyrogenicity, and shelf life and packaging.

The FDA invited comments on the draft by May 30.