U.S. FDA Regulatory Policy for Digital Health and Software Products
- US FDA's Regulatory Policy for Digital Health and Software Products The US Food and Drug Administration's (FDA) digital health regulatory policy has come a long way in the past five years since the 2016st Century Cures Act was passed in 21. The Cures Act requires FDA to provide support for Real World Evidence, Premarket Review of medical device accessories, Expedited Drug Development, and Breakthrough Device [...]


