Fitbit Selected to Participate in FDA’s New Digital Health Software Precertification Pilot Program

Fitbit’s goal in participating is to help create an inclusive and efficient regulatory path for software as a medical device

SAN FRANCISCO--()--Fitbit (NYSE: FIT), the leading global wearables brand, announced today 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.”

Over the last 10 years, Fitbit has become synonymous with health and fitness, 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.

About Fitbit, Inc. (NYSE: FIT)

Fitbit helps people lead healthier, more active lives by empowering them with data, inspiration and guidance to reach their goals. As the leading global wearables brand, Fitbit designs products and experiences that track and provide motivation for everyday health and fitness. Fitbit’s diverse line of innovative and popular products includes Fitbit Surge®, Fitbit Blaze®, Fitbit Charge 2®, Alta HR™, Alta®, Fitbit Flex 2®, Fitbit One® and Fitbit Zip® activity trackers, as well as the Fitbit Ionic™ smartwatch, Fitbit Flyer™ wireless headphones and Fitbit Aria® and Fitbit Aria 2™ Wi-Fi Smart Scales. Fitbit products are carried in 55,000 retail stores across 65 countries around the globe. Powered by one of the world’s largest social fitness networks and databases of health and fitness data, the Fitbit platform delivers personalized experiences, insights and guidance through leading software and interactive tools, including the Fitbit and Fitbit Coach apps, Guided Health Programs, and the Fitbit OS for smartwatches. Fitbit Health Solutions develops health and wellness solutions designed to help increase engagement, improve health outcomes, and drive a positive return for employers, health plans and health systems.

Fitbit and the Fitbit logo are trademarks or registered trademarks of Fitbit, Inc. in the U.S. and other countries. Additional Fitbit trademarks can be found at Third-party trademarks are the property of their respective owners.

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Fitbit, Inc.
Jen Ralls, 415-941-0037


Fitbit, Inc.
Jen Ralls, 415-941-0037