Strengthen the Clinical Trial Enterprise
Goal: Improve the efficiency, consistency, and predictability of the IDE process to reduce the time and number of cycles needed to reach appropriate IDE full approval for medical devices, in general, and for devices of public health importance, in particular.
Goal: Increase the number of early feasibility/first-in-human IDE studies submitted to FDA and conducted in the U.S.Strike the Right Balance Between Premarket and Postmarket Data Collection
Goal: Assure the appropriate balance between premarket and postmarket data requirements to facilitate and expedite the development and review of medical devices, in particular high-risk devices of public health importance.Provide Excellent Customer Service
Goal: Provide excellent customer service.