This guidance describes how FDA intends to apply its drug labeling authorities to certain software outputs that are disseminated by or on behalf of a drug sponsor for use with a prescription drug or a prescription drug-led, drug-device combination product (hereafter referred to as a “combination product”) that is assigned to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) as the lead center.


This guidance expands on and was developed in response to comments submitted in response to the Federal Register notice “Prescription Drug-Use-Related Software; Establishment of a Public Docket; Request for Comments.