FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know
FDA Law Blog
OCTOBER 10, 2023
By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. We find that this information is noteworthy for manufacturers to consider.
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