FDA Highlights Mobile App Innovation, Cites De Novo Reviews

FDA Commissioner Scott Gottlieb and CDRH Director Jeff Shuren hailed the “reimagination” of health care delivery through mobile medical apps and cited steps the agency is taking to encourage innovations in the rapidly developing market.

The agency has granted Apple de novo status for two mobile medical apps that will be featured in the latest incarnation of the Apple Watch. One app creates an electrocardiogram to detect atrial fibrillation and regular heart rhythm, while the other analyzes pulse rate data to notify users of irregular heart rhythms.

The agency worked closely with Apple throughout the development and testing, Gottlieb and Shuren noted in a joint statement. They also cited other actions the agency has taken to promote digital health innovation, such as the launch of the Digital Health Innovation Action Plan last summer, which laid out a blueprint for issuing medical software guidance, revamping digital health product oversight and increasing agency expertise in digital health.

The agency is also trying out a precertification pilot program to help determine how it should regulate digital health products (IDDM, June 25). — James Miessler