The U.S. Food and Drug Administration has selected nine companies for its pre-certification pilot program that aims to streamline the digital health regulation process. Selected out of more than 100 applications, the group spans both startups and big corporations, and also includes one non-profit.
“Our method for regulating digital health products must recognize the unique and iterative characteristics of these products,” FDA Commissioner Dr. Scott Gottlieb said in a statement. “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.”
Selected organizations include:
- Apple – which is well versed in the digital health space with a trio of platforms (HealthKit, CareKit and ResearchKit) and the single most popular smartwatch (Apple Watch).
- Fitbit – one of the biggest wearable device makers with millions of users from all corners of the world.
- Johnson & Johnson – it too has been engaged in the digital health space through few of its subsidiaries and their partnerships with other companies.
- Pear Therapeutics – it was the first company to get cleared for a digital therapeutic.
- Phosphorus – which provides genetic tests through its CLIA-certified lab, and is also working on analytics tools to support these tests.
- Roche – the pharma giant has been meddling in the digital diabetes management space for years. Earlier this year, it acquired the interactive diabetes management app developer mySugr.
- Samsung – thanks to its wide reach, Samsung Health is one of the most popular fitness apps on the market. The Korean giant is also exploring the use of virtual reality in clinical settings.
- Tidepool – a nonprofit developing open-source tools in support of people with Type 1 diabetes.
- Verily – formerly known as Google Life Science division, the company has been launching a number of initiatives to tackle different areas of health. One of its latest efforts, the Project Baseline study, will include 10,000 volunteers to search for new predictors of disease through a combination of clinical tests and passive monitoring with wearables.
FDA will hold a public workshop in January 2018 to report on and review their initial findings, as well as provide public updates via the pilot program webpage and through stakeholder meetings.
The FDA launched the Pre-cert pilot program on July 27, as part of the agency’s Digital Health Innovation Action Plan to foster digital health innovation. The pilot program will focus on looking at the software developer or digital health developer first, instead of traditionally looking primarily at the product.