FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know
FDA Law Blog
OCTOBER 10, 2023
airport security screening), or surgical procedures, as well as the potential for reoperation or revision of the implant. Performance data should be customized to the indications for use, including the specific intended patient population (adult vs. pediatric), disease state, conditions of use, and the target anatomical location.
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