“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.”
“That’s why I announced in the Digital Health Innovation Action Plan that the FDA would pilot a Digital Health Precertification (Pre-Cert) Program to make sure that patients continue to have access to new treatments that meet our gold standard for safety and effectiveness. Since that announcement, we’ve been advancing policies that reimagine our oversight of digital health tools to be more efficient and promote patient safety throughout the product lifecycle. We’ve seen the promise of innovation in products like artificial intelligence software that can help alert physicians to a potential stroke and smart watches that can help identify atrial fibrillation. Today, we’re announcing that, based on the Pre-Cert pilot, we’ve drafted a regulatory framework to test new approaches for the review of digital health device applications.”
“Our goal in piloting the Pre-Cert Program was to support the development of new technologies that are frequently updated, as well as to learn from software developers about the unique nature of their products…” Read the full statement here.
Source: 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 – January 7, 2019. FDA.
