Fitbit Selected to Participate in FDA’s New Digital Health Software Precertification Pilot Program
September 26 2017 - 12:49PM
Business Wire
Fitbit’s goal in participating is to help
create an inclusive and efficient regulatory path for software as a
medical device
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
www.fitbit.com/legal/trademark-list. Third-party trademarks are the
property of their respective owners.
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Fitbit, Inc.Jen Ralls, 415-941-0037PR@fitbit.com
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