Apple, Samsung and Fitbit are among other companies the U.S. Food and Drug Administration has chosen for a pilot program that is aimed to speed up the acceptance of health technology, like software and products, the agency announced Tuesday.

Out of more than 100 interested companies, the FDA also chose U.S. firms Johnson & Johnson, Pear Therapeutics, Verily, Tidepool, Phosphorus, as well as Swiss company Roche. The nine companies will participate in a “first-of-its kind pilot program that will help revolutionize digital health regulation in the U.S,” the FDA said.

Through the program, the FDA will look at a software developer or digital health technology developer overall instead of just focusing on one product at a time, like it currently does with drugs and medical gadgets. The program would pre-certify companies, hence making the development of products a quicker process.

"Our method for regulating digital health products must recognize the unique and iterative characteristics of these products," FDA Commissioner Scott Gottlieb said in a statement. "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."

Acceptance to the program is good for Apple, since it’s focusing on health-related technology, as seen with the recently released Apple Watch Series 3 that includes heart rate sensors. Fitbit, which sells activity trackers should also benefit from lighter regulations.

Through the program, Apple, Samsung, Fitbit and the other companies agreed to allow the FDA to see how they develop, test and maintain their software products, as well as ways the firms collect post-market data. The companies will also let the agency’s staff conduct visits at their sites and will provide information about their quality management system. The FDA said it will use the information to “build its expertise in the areas” and to “provide proper oversight” of products and firms.

The FDA listed the following goals for the program:

  • enable a modern and tailored approach that allows software iterations and changes to occur in a timely fashion;

  • ensure high quality medical product software throughout the life of the product by enabling companies to demonstrate their embedded culture of quality and organization excellence (CQOE); and

  • be a program that learns and adapts and can adjust key elements and measure based on the effectiveness of the program.

The FDA will share updates about the pilot program on its site and through stakeholder meetings. The agency said will receive feedback throughout the pilot from participating companies, the industry, stakeholder groups and the public.

“This feedback will be invaluable as we progress through the pilot and onto the next stages of digital health oversight,” Bakul Patel, associate director for digital health in the FDA’s Center for Devices and Radiological Health, said in a statement.

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