Regulation of Digital Health Products by FDA
- DHV-NET
- Jul 10, 2023
- 1 min read
The FDA has undertaken a risk-based approach to regulating software that may be considered a medical device and has attempted to clarify what is and what is not a device in several guidance documents. Of unique interest to developers are software programs that run on smartphones and other mobile communication devices, including accessories that attach to a smartphone or other mobile communication devices, or a combination of accessories and software.
