Off-Label Dissemination Rule's "Supplement" Definition May Be Revisited
This article was originally published in The Gray Sheet
Executive Summary
FDA likely will reexamine whether a device being marketed via a 510(k) that has a new off-label indication requiring a premarket approval application would be eligible for dissemination of journal articles on that unapproved use under FDA's proposed rule on "Dissemination of Information On Unapproved/New Uses For Marketed Drugs, Biologics & Devices."