The U.S. Food and Drug Administration (FDA) has launched its Medical Device Innovation Initiative to help speed medical devices to the market. The general idea is to improve early interaction between the FDA and vendors to get devices approved more quickly. A new process will be instituted that, among other things, promotes scientific innovation in product development, focuses on cutting edge science, modernize the review of innovative devices, and seeks to improve the overall approach of required clinical trials, according to an FDA release.
"We must keep up with the rapid developments in science and technology to ensure that patients have access to the most advanced treatments available," said Andrew C. von Eschenbach, MD, FDA acting commissioner. "By working with industry early in the evaluation process, we hope to foster development and speed up the approval of safe and effective innovative devices."
As part of this initiative, FDA has issued new guidelines to outline the use of adaptive clinical trial designs. The guidelines provide FDA's recommendations on the use of Bayesian statistical methods in the design and analysis of medical device clinical trials.
"Although this guidance is not yet final, it is a very exciting move in the direction of expediting new technology to the public," said Daniel Schultz, MD, director, Center for Devices and Radiological Health (CDRH).
With hopes to create shorter, cheaper trials, the use of Bayesian statistics offers the industry the option of using prior, legally available information about safety and/or effectiveness in a mathematically acceptable way to design more efficient, scientifically viable trials, the FDA said.