The FDA wants medical device developers to join them in facilitating a smoother, quicker approval process.
A proposed Medical Device Development Tools qualification process would affect measurement tools that assess medical device performance, safety, and effectiveness, according a notice FDA posted to the Federal Register on Friday. The MDDT Pilot Program could benefit both manufacturers and regulators, with the FDA accepting nominations for program participants starting September 14.
The FDA expects that manufacturers can better rely on MDDTs that have been FDA reviewed and accepted qualified, and made available through this program. Currently clinical trials face dismissal or regulator denunciation after finding that a measurement tool overlooks an important variable, lacks precision or somehow falls short of its intended use.
A draft guidance document released by FDA in November 2013 , called "Medical Device Development Tools," outlined the agency’s new approach. Instead of each FDA device review team evaluating data justifying MDDT use for an individual product or setting separately, new tools qualified once for one purpose could then be used within that same context in the future.
The latest FDA notice claims the proposed MDDT process will help close the divide between medical device research and delivery to the public, potentially increase clinical study efficiency, and further the FDA’s goal to strengthen the clinical trial enterprise.
Accepted proposals will share certain characteristics. According to the post, "FDA plans to prioritize proposals based on public health need or potential to impact multiple device development programs. Additionally, for the purposes of the pilot, proposals are expected to be prioritized based on feasibility, timeline, and FDA resources."
Currently, the FDA plans accept up to 15 candidates, ideally MDDTs that meet a public health need and could affect multiple device development programs.
