FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know
FDA Law
OCTOBER 10, 2023
airport security screening), or surgical procedures, as well as the potential for reoperation or revision of the implant. Non-Clinical Recommendations The draft guidance highlights non-clinical review areas that are generally relevant across 510(k) Implants and offers recommendations for performance data to include in a 510(k) submission.
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