Bioethics Blogs

I <3 Intended Use (and why some new technologies may fall within FDA jurisdiction)

Cross-posted on Objective Intent

A few news stories over the past week or so—one in the Wall Street Journal about “neurotech,” one in Geek Gadget about “neuroscience wearables,” one in the Washington Post about baby monitors for measuring an infant’s vital signs, and one in Gizmodo about “vaginal wellness products” marketed on Etsy—reminded me how much I enjoy questions of intended use.  As I wrote more about here, intended use is a critical concept in FDA law, in part because a product’s intended use is crucial to determining whether it meets the law’s definition of drug or device within the FDA’s jurisdiction.  And, for whatever reason, I have an unabashed and—as far as I can tell—limitless love for thinking through questions about whether, and how, products fall with the definition of a drug or device.

As for the reported neurotech, neuro-wearable, baby monitor, and vaginal wellness products, it seems to me that many of these products may fall within the Federal Food, Drug, and Cosmetic Act’s (FDCA) definitions of drugs or devices.  Why is that?

The FDCA defines drugs and devices as products “intended for use” in the diagnosis, cure, mitigation, treatment, or prevention of diseases, or “intended to affect the structure or any function of the body.”  And this definition is very broad.

The “disease” piece of the definition captures things like cancer therapies and artificial heart valves—products that fit comfortably within what many commonly understand to be drugs and devices subject to FDA regulation.  But, because implicit claims about addressing disease can also cause a product to fall with the definition of a drug or device, this part of the definition also might capture things like baby monitors marketed as measuring breathing and oxygen levels.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.