The FDA has announced new goals to help modernize its procedures and respond to new technologies. In a blog post by FDA Commissioner Scott Gottlieb, M.D., the agency expressed new priorities to help modernize clinical trials for medical devices and develop standards for new technologies like artificial intelligence.
According to Gottlieb, clinical trials “are becoming more costly and complex to administer” while “new technologies and sources of data and analysis make better approaches possible.” In order to take advantage of these better approaches, Gottlieb pointed to the FDA’s Breakthrough Devices Draft Guidance, which proposes streamlined procedures to develop flexible clinical trial designs for important medical devices. This will allow the FDA to “evaluate . . . innovative devices more efficiently.” Six breakthrough devices have already been cleared using this program.
Additionally, Gottlieb discussed the FDA’s new goal of enabling the use of “real-world evidence” to support decisions to approve devices. According to Gottlieb, “[r]eal world evidence can help answer questions that are relevant to broader patient populations or treatment settings where information may not be captured through traditional clinical trials.” The FDA is helping to design several proof-of-concept trials that utilize real-world evidence.
Finally, Gottlieb discussed the FDA’s role in dealing with new and emerging technologies. In particular, Gottlieb discussed artificial intelligence, which “holds enormous promise for the future of medicine.” Medical artificial intelligence models are currently in development and the FDA recently approved an AI algorithm for detection and treatment of distal radius fractures. According to Gottlieb, the FDA is exploring ways to handle and evaluate the kinds of data that are relevant to AI performance and safety, hoping to “enable a transparent benchmarking system for AI algorithm’s performance.”
Gottlieb concludes that the FDA has “undertaken a comprehensive effort to make sure that our organization and policies are as modern as the technologies we’re being asked to evaluate, and that we’re able to efficiently advance safe, effective new innovations.”