The Center for Devices and Radiological Health (CDRH) has followed the advice of Advisory Committees to approve or not approve a product 89% of the time. Using the resources of our firm, 3D Communications, the authors conducted a survey of current and former members of FDA Medical Device Advisory Committees to determine how they prepare and the key factors that influence their thinking.

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On April 13, 2015, FDA issued two final guidance documents on premarket approval of new medical devices. These documents represent the Agency’s current thinking on when data collection might be pushed from pre-approval to post-approval, with one guidance focused on expedited approval for devices that meet a significant unmet medical need. The following is a summary of the information provided and recommendations for Sponsors looking to take advantage of opportunities to achieve earlier and less expensive medical device approval.

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