Modernizing the FDA's 510(k) Program for Medical Devices: Selection of Predicate Devices and Use of Clinical Data in 510(k) Submissions | Goodwin

On September 6, 2023, the US Food and Drug Administration (FDA) released a trio of draft guidances in its efforts to “strengthen and modernize” the 510(k) Program and provide for more...

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,Drug Administration ,Federal Food ,Cosmetic Act ,Evaluating Substantial Equivalence ,Premarket Notifications ,Predicate Device ,Clinical Data ,Implant Devices ,Medical Device Safety ,Medical Devices Recalls ,