FDA has issued a draft guidance on the Safer Technologies Program (STeP) for Medical Devices to promote expedited development and regulatory review of safety innovations. This is certainly a STeP in the right direction!
Recently, I had an opportunity to hear directly from FDA leaders during a fire-side chat at the Xavier Health AI Summit in Cincinnati, OH. Alonza Cruse, Director, FDA - Office of Regulatory Affairs and Bakul Patel, Associate Director, FDA – Center for Devices and Radiological Health, each shared their views on how AI is shaping FDA’s thinking in nearly all of its operations. It was very encouraging to hear that the FDA wants to build a collaborative relationship with the industry and “stand out of your way” to help realize the true potential of AI in Healthcare.