The FDA just put their Digital Health Action Plan into practice with the announcement of the nine companies chosen as part of their Pre-certification Pilot Program. From pharma, to tech titans, to large and small health technology developers, these companies will usher in the FDA's new approach to digital health medical devices.
Congratulations to Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool, and Verily!
"Our method for regulating digital health products must recognize the unique and iterative characteristics of these products," said Dr. Gottlieb. "We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices. These pilot participants will help the agency shape a better and more agile approach toward digital health technology that focuses on the software developer rather than an individual product."