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.
The agency will begin seeking public comment on a framework by which to consider data requirement shifts and devise a process by which to assess the pre- and post-market data collection balance, according to an FDA memo.
Ultimately, the CDRH hopes to provide better service to its customers, defined as patients, industry and healthcare workers. The agency hopes by the end of 2015 to achieve a score of at least 90% customer satisfaction, to be assessed by new survey tools and a program to monitor and address feedback.
"By providing excellent customer service, we do not alter our regulatory obligations," the agency said. "Customer service does not mean letting unsafe or ineffective devices on the market – rather it requires identifying and meeting our customers’ needs, as appropriate, while achieving our mission and vision."
