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Comments Sought on Device Premarket/Postmarket Data Collection

04/29/2015

Federal Register Notice: FDA reports on CDRH’s progress on its 2014-2015 Strategic Priority “Strike the Right Balance Between Premarket and Postmarket Data Collection.” To achieve this priority, CDRH established a goal to assure the appropriate balance between premarket and postmarket data collection to facilitate and expedite the development and review of medical devices, in particular high-risk devices of public health importance, and established a target date of 12/31/14, by which to review 50% of product codes subject to a PMA that are legally marketed to determine whether or not, based on the agency’s current understanding of the technology, to rely on postmarket controls to reduce premarket data collection, to shift some premarket data collection to the postmarket setting, or to pursue down-classification. Comments on this topic should be submitted by 6/29. To view this notice, click here.

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