--- title: The FDA's New Approach to Digital Health • Generis description: Recognizing that their traditional approach for hardware-based medical devices is not well suited for software products, the FDA has created a new Digital Health Innovation Action Plan.One important piece of this plan is the “Software Pre-Certification (Pre-Cert) Pilot Program”. image: https://blog.generisgp.com/hubfs/pngtree-blue-business-technology-information-security-banner-background-image_260807.jpg --- [Skip to content](https://blog.generisgp.com/blog/2018/02/14/fdas-new-approach-digital-health#main-content) [![Generis Logo full Colour (Large) (1)](https://blog.generisgp.com/hs-fs/hubfs/Generis%20Logo%20full%20Colour%20(Large)%20(1).png?width=773&height=112&name=Generis%20Logo%20full%20Colour%20(Large)%20(1).png "Generis Logo full Colour (Large) (1)")](https://blog.generisgp.com/blog) - [Medical Device](https://blog.generisgp.com/blog/tag/medical-device) # The FDA’s New Approach to Digital Health - February 14, 2018 [Generis](https://blog.generisgp.com/blog/author/generis) Recognizing that their traditional approach to moderate and higher-risk, hardware-based medical devices is not well suited for the more rapid and iterative design, development, and validation phases used for software products, the FDA has created a new [Digital Health Innovation Action Plan](https://www.fda.gov/downloads/MedicalDevices/DigitalHealth/UCM568735.pdf). One important piece of this plan is the “Software Pre-Certification (Pre-Cert) Pilot Program”. This pilot program, which began on September 1, 2017, is a voluntary program that will enable the FDA to develop a tailored approach toward regulating digital health technologies by looking first at the software developer and/or digital health technology developer, rather than the product. The purpose of this is to streamline the regulatory process for companies with a history of developing and testing quality products. Once pre-certified, that developer would be empowered to make software iterations and changes as needed. The nine participants that have been [selected](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm577480.htm) for the Software Pre-Cert Pilot Program are Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorous, Roche, Samsung, Tidepool, and Verily. According to the FDA, these participants were chosen as they “represent a wide range of companies and technology in the digital health sector, including small startups and large companies, high- and low-risk medical device software products, medical product manufacturers and software developers.”   Read our latest article on [“The FDA’s New Approach to Digital Health,”](https://generisgp.com/wp-content/uploads/2018/02/The-FDAs-New-Approach-to-Digital-Health-Software-Pre-Cert-Pilot-Program.pdf) which answers the following questions: - Why is the FDA trying to develop a new regulatory approach for software as a medical device? - What types of products are within the scope of the program? - Why is the FDA focusing on software for this pilot? - Is the FDA committed to this pilot program and new approach to digital health? - What are some key goals of the Software Pre-Cert Program? - Will startups and smaller companies be eligible for the software Pre-Cert Program? 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