Tag Archives: pre certification

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new actions under the Pre-Cert Pilot Program to promote a more efficient framework for the review of safe and effective digital health innovations

Digital technologies create new opportunities to transform health care and empower patients to make better informed decisions about their health. Digital tools are rapidly evolving, and to keep pace with this promising innovation, the FDA must modernize its approach to regulation.

FDA