On February 5th, the CDRH released its strategic priorities for 2014 and 2015. This is the first time the device center has released a two-year strategic plan rather than an annual plan. The center is focusing on strengthening the clinical trial enterprise, striking the right balance between pre-market and post-market data collection, and providing excellent customer service.
In an interview with The Gray Sheet,” Director Jeffrey Shuren indicated that the priorities specifically focus on ways to address barriers to accomplishing their vision for patients in the United States to get first-in-the-world access to high-quality, safe and effective medical devices.
The “Entrepreneurs in Residence” program consisting of a group of outside experts working inside the medical device center provided recommendations last spring to the agency on clinical trial reform and balancing pre-market/post-market data collection. These recommendations were the catalyst behind the outlined strategic priorities according to Shuren.
- Rebalancing Data Collection – The agency is developing a new pathway to for high-risk PMA devices that address unmet medical needs, by shifting some of the evidence burden from pre-market trials to the post-market studies and incorporating features from the center’s prior innovation pilots.
- Clinical Trial Reform – The center is also planning to improve the efficiency, consistency and predictability of the investigation device exemption process to reduce the time and number of cycles needed to reach IDE approval.
- Customer Satisfaction - CDRH is also prioritizing excellent “customer service” to patients, manufacturers and healthcare professionals. They are targeting 90% customer satisfaction by December 2015.
This plan is different than previous plans as it if focused on particular outcomes as opposed to particular actions and outputs. Director Shuren is pleased with their progress and feels they are moving forward to accomplish their vision.
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