CDRH Focusing On New PMA Pathway, Clinical Trials Program In 2014/2015 Priorities
This article was originally published in The Gray Sheet
Executive Summary
CDRH Director Jeffrey Shuren discussed the device center’s two-year strategic priorities with “The Gray Sheet.” The center plans to rebalance pre-market and post-market data collection, when appropriate, and improve the processes for starting up clinical trials in the U.S.
You may also be interested in...
Are You On The List? FDA ID’s Devices That Might See Less Premarket Data Or Downclassification
CDRH says it exceeded its goal to retrospectively review half of all pre-2010 PMA device types. So far, 21 categories have been slated as candidates for downclassification and another 21 may be tagged for shifting some data requirements to the postmarket.
FDA Guidance Allows Limited Foreign Data To Approve Devices With Postmarket Caveat
As FDA puts more emphasis on postmarket data collection in its PMA approval process, the agency has released a final guidance on balancing premarket and postmarket studies.
FDA Panel To Consider Data Shift For Pediatric Cochlear Implants
The Ear, Nose and Throat Devices Panel will convene for two days, April 30 and May 1, first to recommend risk-classification categories for five types of hearing devices and, on the second day, consider the potential of moving clinical requirements for cochlear implant modifications for kids to the postmarket phase.