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Modernizing the FDA's 510(k) Program for Medical Devices: Se
Modernizing the FDA's 510(k) Program for Medical Devices: Se
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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