The FDA’s office of medical device review released its priorities for the year ahead, saying that it plans to focus on its clinical trial process and promote a better balance between pre- and post-market data aggregation. The Center for Devices & Radiological Health outlined 3 main priorities for 2014: strengthening the clinical trial program, striking a balance between Medtech data collection efforts before and after market approval and providing better services to its many “customers.”
In streamlining its clinical trial programs, the CDRH said that it hopes to provide more efficiency, consistency and predictability for applications submitted for Investigational Device Exemption, which gives companies freedom to conduct U.S. clinical trials to support bids for market approval. The agency plans to reduce the number of applications that require multiple cycles before landing IDE approval and to encourage greater submissions of IDE studies. To do so the FDA will create a “premarket clinical trials program” to manage IDE performance, formalize its benefit-risk calculation system, establish a process by which to handle application-specific issues and develop education programs and metrics to measure performance.
To improve its data collection processes, seeking to shorten devices’ time to approval and thus U.S. patient’s time to access new therapies. CDRH will consider shifting some of its pre-market data requirements to the post-market time-frame, examining different categories of devices for potential downgrades to less-stringent classifications.