Elizabeth Guo

Elizabeth Guo received her law degree from Harvard Law School and her M.P.H. from the Harvard School of Public Health in 2016.

Subscribe to all posts by Elizabeth Guo

FDA Issues Updated Guidance on the Regulation of Digital Health Technologies

On September 26, 2019, the FDA issued two revised guidance documents addressing its evolving approach to the regulation of digital health technologies.  These guidances primarily describe when digital health solutions will or will not be actively regulated by FDA as a medical device.  In parallel, FDA also updated four previously final guidance documents to ensure … Continue Reading