FDA picks 9 vendors for digital health software precertification pilot
The Food and Drug Administration has selected nine technology vendors to participate in a new software precertification pilot program for developers aimed at fast-tracking digital health products to market.
The agency’s pilot will help it assess how precertified companies could bring certain types of consumer and patient applications to market without FDA premarket review or after a more streamlined premarket review process.
The agency received interest in the program from more than 100 vendors and selected nine participants for the pilot, including:
- Apple, Cupertino, California
- Fitbit, San Francisco, California
- Johnson & Johnson, New Brunswick, New Jersey
- Pear Therapeutics, Boston, Massachusetts
- Phosphorus, New York, New York
- Roche, Basel, Switzerland
- Samsung, Seoul, South Korea
- Tidepool, Palo Alto, California
- Verily, Mountain View, California
“We are extremely appreciative of the tremendous interest in participating in the FDA Pre-cert pilot program,” said Bakul Patel, associate director for digital health in the FDA’s Center for Devices and Radiological Health. “The number of applicants speaks to the significant impact this approach could have on facilitating timely advancement of software that has the potential to benefit health.”
According to the FDA, it considered several factors in picking the companies including size, demonstrated record of quality and organizational excellence, clinical focus area, and the risk profile of their products. Ultimately, the agency contends that a broad mix of vendors were selected including startups, established companies, high- and low-risk medical device software products, as well as medical product manufacturers and software developers.
“The diversity of the Pre-cert pilot program participants means that we will receive a variety of input on how the industry defines organizational excellence and other key performance indicators,” added Patel. “This feedback will be invaluable as we progress through the pilot and onto the next stages of digital health oversight.”
The nine pilot participants will serve as use cases to build a future precertification program including the criteria to assess whether a company consistently and reliably engages in high-quality software design, testing, and ongoing maintenance of its products.
Toward that end, participants will provide access to measures they currently use to develop, test and maintain their software products, including methods they collect post-market data. In addition, they will be available for site visits from FDA staff, and provide information about their quality management system.
“We applaud the FDA for taking a progressive and thoughtful approach to designing a potential new digital health regulatory framework and are proud to have been selected to participate in this innovative pilot program,” said James Park, co-founder and CEO of Fitbit. “As Fitbit takes a more integrated role in personal healthcare, we are hopeful this will allow us to accelerate FDA regulated features and software development, bringing new capabilities that could positively impact health outcomes to market more quickly.”