The FDA’s New Approach to Digital Health

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.

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 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,” 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?