In the August 8, 2016, Federal Register, the Center for Devices and Radiological Health ("CDRH") announced that—as a part of its 2014-15 Strategic Priority to "Strike the Right Balance Between Premarket and Postmarket Data Collection"—the Center completed its goal of retrospectively reviewing 100 percent of all Premarket Approval ("PMA") product codes ("procodes") with active PMAs that were approved before 2010 to assess whether premarket data collection could be shifted to the postmarket setting or reduced through reliance on postmarket controls and whether reclassification could be appropriate based on the Agency's updated understanding of the relevant technologies. The results of CDRH's review are available online, which are additive to results previously reported in April 2015. While CDRH continues to consider comments on the April 2015 results, it seeks comments on the additional procodes identified as candidates for reclassification, a reduction in premarket data collection through reliance on postmarket controls, or a shift in data collection from premarket to postmarket. FDA is prioritizing the identified procodes according to public health impact and Center resources. Firms that are developing a device in an affected category should seek feedback on their data collection plan through a presubmission or contact the appropriate review branch to obtain additional information. Comments are due October 7, 2016.

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