The Logical Outgrowth Doctrine and FDA’s Intended Use Revisions

Cross-Posted on Notice & Comment

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 be crucial to determining whether a product is a drug or device subject to FDA oversight at all, and whether an FDA-authorized drug or device is in compliance with FDA requirements. (Readers can find more about “intended use” generally, and the background behind the current controversy, here). Because “intended use” is so important in the FDA world, it should come as no surprise that stakeholders that disagree with the revised definition in the January final rule—which has yet to go into effect—have lodged both procedural and substantive arguments against the revision (see, e.g., here and here).

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The Intended Use Hullabaloo

In the spirit of our blog’s title, this is the first of several posts to tackle the FDA’s controversial revisions to its regulations defining “intended use” and describing the evidence relevant to determining a product’s intended use.  This post covers the background—what has happened, and why it is important.  Subsequent posts will cover some of the substantive and procedural concerns that have been raised about the agency’s revisions.

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