FDA’s Bakul Patel On Pre-Cert Pilot Program

FDA’s Bakul Patel discussed the agency’s pre-certification pilot program formerly known as the precheck program. If successful the program would allow medical device sponsors to get their digital health products to market potentially sooner and more streamlined based on trust they build with FDA. In some cases sponsors may not even need to file a premarket application. Tags: medical device, fda, pre-certification, precheck, bakul patel, digital health, digital health innovation action plan