The FDA recently announced their Digital Health Software Precertification (PreCert) Program, which is a piece of the Digital Health Innovation Action Plan. The goals of this program are to:
- enable a modern and tailored approach that allows software iterations and changes to occur in a timely fashion;
- ensure high quality medical product software throughout the life of the product by enabling companies to demonstrate their embedded culture of quality and organization excellence (CQOE); and
- be a program that learns and adapts and can adjust key elements and measure based on the effectiveness of the program.
The first 9 participants in the program have already been announced by the FDA:
- Apple, Cupertino, California
- Fitbit, San Francisco, California
- Johnson & Johnson, New Brunswick, New Jersey
- Pear Therapeutics, Boston, Massachusetts
- Phosphorus, New York, New York
- Roche, Basel, Switzerland
- Samsung, Seoul, South Korea
- Tidepool, Palo Alto, California
- Verily, Mountain View, California
Keep an eye on the pilot program webpage for updates and the details for the January 2018 workshop.