FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know
FDA Law Blog
OCTOBER 10, 2023
Implant devices are used in a range of settings such as dental and orthopedic procedures. Having a clear understanding of FDA’s data expectations for 510(k) applications related to implants is crucial for successful marketing clearance. The intended duration of implantation is another crucial factor in performance testing.
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