In 2017, the FDA launched its Digital Health Pre-Certification Program, also known as Pre-Cert, to work with innovators to develop a new approach to regulatory oversight for software-based medical technologies. Nearly two years into the pilot program, we wanted to get a status update and hear what’s in store for the program this year and beyond. Rock Health Managing Director and CEO Bill Evans caught up with Bakul Patel, the FDA’s Director for Digital Health, and Jared Seehafer, cofounder and CEO of Rock Health portfolio company Enzyme, to discuss the FDA’s new look as well as how startups should navigate—and participate in—the evolving regulatory process.
The FDA recently released its proposed regulatory framework for AI/ML-based software as a medical device (SaMD) and is requesting feedback from the digital health community. Have thoughts to share? The FDA is all ears—comments are due here by June 3. You can contact the FDA specifically about Pre-Cert by emailing FDApre-certPilot@fda.hhs.gov.