The US Food and Drug Administration has announced the names of nine companies that have been selected as partners for its pilot program that will help in revolutionizing digital health regulation in the country. Samsung is a part of the pilot program, and so are Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Tidepool, and Verily. These brands are considered to be the innovators and leaders in the medical device and technology sectors. The program has received interest from more than 100 brands.
The FDA's digital health software pre-certification program will help in taking a tailored approach towards digital health technology's software rather than focussing on the end product. The FDA will review the software design, validation, and maintenance to determine whether a company has met quality standards, and if it did, it would be a pre-certified. With the information received from the pre-certification program, the FDA will determine key metrics and performance indicators.
The companies who receive the pre-certification can submit less data than what is currently required before launching new health-related products. The pre-certified companies may not be required to send their new products like fitness and health tracking devices to the FDA for premarket reviews in some cases. The FDA launched the pre-certification pilot program on July 27 as a part of its Digital Health Innovation Action Plan. In selecting the first group of companies, the agency considered a lot of factors such as the company size, track record, and more.
“Our method for regulating digital health products must recognize the unique and iterative characteristics of these products. 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,” said Dr. Gottlieb.
As a part of the program, the participant companies have agreed to provide access to measures they use to develop, test, and maintain their software products. They have also accepted to provide the agency with post-market data. The companies will also be available for site visits from the agency staff. The agency, in partnership with top brands, wants to improve the health measuring and tracking tools as well as software, which will benefit the end users.
