Fitbit announced that it has been selected as one of nine companies that will participate in the U.S. Food and Drug Administration’s (FDA) new digital health software precertification pilot program.
The pilot aims to develop a new approach to regulating digital health technology and promotes the innovation of high-quality and effective digital health tools. Fitbit plans to work with the FDA on this effort, which would enable companies to bring new tools to consumers that have the potential to improve health outcomes and advance digital health innovation.
By exploring the development of a new regulatory pathway, the FDA intends to create a process that initially evaluates the software developer, rather than the digital health product itself – a departure from the way traditional medical devices and products are evaluated today. Under this approach, companies that have shown they meet necessary quality standards could be precertified, enabling them to more quickly introduce new regulated products.
“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.”
Fitbit has been delivering innovative features such as PurePulse continuous wrist-based heart rate tracking and providing health insights to millions of users that they previously could only have received using expensive equipment or in a lab, such as Sleep Stages and Insights, and Cardio Fitness Level. The company is also participating in clinical trials to validate the efficacy of technology to screen for conditions like Sleep Apnea and Atrial Fibrillation, with promising early results. Fitbit will bring to the program its expertise in evidence-based innovation and in developing engaging experiences and tools that help motivate and inspire consumers to make behavior changes that can help improve health outcomes.
FDA has provided the following requirements for companies participating in the pilot program:
- Provide access to its measures for developing, testing and maintaining software products and demonstrating a culture of quality and organizational excellence measures by KPI;
- Collect real-world post-market data and provide it to FDA;
- Meet with FDA for real-time consultation;
- Be available for site visits from FDA officials; and,
- Provide information about its quality management system.
