Tag Archives: Logical Outgrowth

The Logical Outgrowth Doctrine and FDA’s Intended Use Revisions

by Patti Zettler — Tuesday, July 18, 2017@pzettler

Cross-Posted on Objective Intent In January FDA published a controversial revision to its regulations defining a product’s “intended use” that, among other things, has raised an interesting logical outgrowth question. “Intended use” is an important concept in FDA law because a product’s intended use—judged by the “objective intent of the persons legally responsible for the [product’s] labeling”—can […]