FDA INITIATIVE MEANT TO FACILITATE DEVICE DEVELOPMENT, AVAILABILITY
The FDA has announced its Medical Device Innovation Initiative, which aims to make new technology available to patients more rapidly, the agency said.
The initiative promotes early interaction between the FDA and industry to optimize review times and foster innovation, the agency said. In a revised edition of the report issued May 23, the FDA said its Center for Devices and Radiological Health (CDRH) will "expand current efforts to promote scientific innovation in product development, focus device research on cutting edge science, modernize the review of innovative devices, and facilitate a least burdensome approach to clinical trials."
The initiative includes new guidelines outlining the use of adaptive clinical trial designs. The draft guidance, "Bayesian Statistics in Medical Device Clinical Trials," provides the FDA's recommendations on the use of Bayesian statistical methods in the design and analysis of medical device clinical trials.
The Medical Device Innovation Report accompanying the announcement sets forth specific aspects of the agency's efforts to promote innovation and efficiency in its medical device review, development and approval processes.