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

Article preview from "The Gray Sheet"- February 5, 2014

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.

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

Article preview from "The Gray Sheet"- February 5, 2014

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 trials enterprise, striking the right balance between pre-market and post-market data collection, and providing excellent customer service.

In an interview, CDRH Director Jeffrey Shuren said the 2014/2015 priorities specifically focus on ways to address barriers to accomplishing their vision for patients in the U.S. to get first-in-the-world access to high-quality, safe and effective medical devices.

“Two of the biggest barriers we identified … were the challenges with the clinical trial enterprise in the U.S. and ensuring we strike the right balance between what’s necessary to demonstrate prior to marketing, before we can let a safe and effective device on the market, and what are the things that we appropriately instead address post-market,” he said.

CDRH’s Entrepreneurs in Residence program, which consisted of a group of outside experts working inside the device center, provided recommendations to the agency last spring on clinical trial reform and balancing pre-market/post-market data collection. The goals outlined in the priorities are the initial steps the center is taking to implement these recommendations, Shuren said.

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