In the April 29, 2015, Federal Register, FDA's Center for Devices and Radiological Health ("CDRH") issued a progress update on its 2014–2015 Strategic Priority titled "Strike the Right Balance Between Premarket and Postmarket Data Collection." To achieve this Strategic Priority, CDRH has been conducting a retrospective review of active PMA applications approved prior to 2010, in order to determine the appropriate level of premarket review for certain Class III medical devices. As of the end of 2014, CDRH had reviewed 69 percent of the product codes slated for retrospective review. The agency's updated report provides recommendations for product codes that are candidates for reclassification, a reduction in premarket data collection through reliance on postmarket controls, or a shift in premarket data collection to postmarket collection. Comments are due June 29, 2015.
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