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CDRH Focusing On New PMA Pathway, Clinical Trials Program In 2014/2015 Priorities

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.

FDA’s device center plans to establish a new PMA pathway for high-risk devices for unmet medical needs and appoint a new director to oversee the pre-market clinical trials program. The plans are part of CDRH’s 2014 and 2015 strategic priorities, released Feb. 5.

This is the first time the device center has released a two-year strategic plan rather than just an annual plan. For 2014/2015, the center is focusing on strengthening the clinical...

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