The FDA has partnered with some of the biggest names in health and technology to modernize consumer health devices and programs. The agency just announced the companies who will be the first to participate in its precertification pilot program under its Digital Health Innovation Action Plan. Apple, Fitbit, Samsung, and Johnson and Johnson are among the nine companies included in the program, meaning they will collaborate with the FDA to create guidelines for other companies to get FDA precertification based on their digital health programs.
The FDA is trying to make it easier for consumers to have access to approved health devices and programs so that each individual can take more responsibility for their own health. Consumers already use wearable devices and health apps to assess general health and specific medical conditions, even though most of these devices do not bear an FDA-approved stamp. The companies participating in this pilot program will help the FDA narrow down "key metrics and performance indicators for precertification" surrounding a company's digital health software.
Software is key to this program because the FDA isn't looking at individual devices made by these participating companies. Rather, the FDA will consult with Apple, Fitbit, and others about what aspects should be included in a company's digital health software in order for it to be "pre-certified."