As with all of our efforts in digital health, collaboration will be key to developing this appropriate framework. We encourage feedback and welcome a diversity of opinions and thoughtful discourse, which will contribute to building the foundation of this regulatory paradigm. As algorithms evolve, the FDA must also modernize our approach to regulating these products. We must ensure that we can continue to provide a gold standard of safety and effectiveness. We believe that guidance from the agency will help advance the development of these innovative products.

We’ve taken similar steps to advance other novel oversight frameworks for new technologies. Our Digital Health Innovation Action Plan laid the groundwork for new approaches to foster innovation in digital health. We’re building our Digital Health Center of Excellence to develop more efficient ways to ensure the safety and effectiveness of technologies like smart watches with medical apps. Our Software Precertification Pilot Program is allowing us to test a new approach for product review. While I know there are more steps to take in our regulation of artificial intelligence algorithms, the first step taken today will help promote ideas on the development of safe, beneficial and innovative medical products.

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