FDA Attorney Services - FDA Regulation of Medical Devices And 510k Clearance

Premarket notification or “510k clearance” is a prerequisite to the marketing and sale of most Class II medical devices. In order to secure a 510k clearance, device sponsors must demonstrate a device’s substantial equivalence to previously cleared devices or be considered substantially equivalent to a device that has been marketed prior to May 28, 1976.

Should you have any questions about your device or how an FDA regulatory attorney may help you with the 510k submission process, please feel free to contact Shehadeh Giannamore, PLLC at (305) 507-9843. You can also visit our website for more details about our FDA attorney services.