Kyle Faget Authors Practical Guidance® Article on CDS Software Final Rule

Foley & Lardner LLP Partner Kyle Faget authored the Practical Guidance^® article, “Clinical Decision Support (CDS) Software Final Rule,” in which she discusses the final guidance recently issued by the U.S. Food and Drug Administration (FDA) addressing clinical decision support software (CDS).

In the article, Faget explains the four criteria certain types of CDS software functions must meet to be excluded from the definition of a medical device, according to the FDA’s final guidance.