Device Experts Say FDA Is Too Heavily Invested In Pre-Cert Program

FDA’s latest report on its software precertification program shows the agency is investing substantial time on the new project, despite not having statutory authority or answering key questions from the industry, device software industry lawyers say. In its report, published Monday (Sept. 14), FDA details ongoing activities for its pre-cert pilot program , which aims to streamline regulatory oversight of software-based medical devices by allowing companies to get precertified by the agency. FDA notes in its report that its learning...