Foley & Lardner LLP Partner Kyle Faget was quoted in the MedTech Dive article, “3 key FDA topics for medtechs in 2022,” about the October 2021 release of the FDA’s list of proposed draft and final medical device guidance documents for fiscal year 2022, including the final guidance on clinical decision support (CDS) software.
Faget said that “The risk-based approach to enforcement that FDA issued previously is not easy for [technology] developers to follow. FDA needs to provide more clarity for developers as to where the boundaries are for each one of those categories.”
Faget is co-chair of Foley’s Health Care and Life Sciences Practice Groups.
