1/21/2019

Medical device makers are calling on the FDA's Center for Devices and Radiological Health to provide a database of products that have been approved under the Breakthrough Devices Program, as well as the rationale, as a way to increase transparency. At a recent FDA webinar, Steve Silverman, AdvaMed's vice president of technology and regulatory affairs, recommended publishing metrics including the total time to FDA decision and the number of requests granted versus denied.

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