FDA Finalizes Review Policy For Multi-Function Devices

FDA last week finalized a review policy for multiple function devices under which it will only review functions for which a device maker seeks clearance or approval. The agency does not plan to review “other functions” of a device unless they could negatively affect the function that’s under review. The agency added clarifications in the final version of the guidance that the Consumer Healthcare Products Association says will help increase innovation. The guidance , released July 28, finalizes the agency’s...