FDA and Digital Health Regulation
DECEMBER 26, 2017
The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Collectively, these guidances cover a range of digital health issues, and it is worth reading FDA Commissioner Scott Gottlieb’s statement about them as well as each individual document: Clinical and Patient Decision Support Software (CDS and PDS) (Draft). Health Care Law and Consulting.