February 28, 2024


Advocacy. Mediation. Success.

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

Cross-posted on Aim Intent

A handful of information tales around the earlier 7 days or so—one in the Wall Street Journal about “neurotech,” a single in Geek Gadget about “neuroscience wearables,” a single in the Washington Article about infant displays for measuring an infant’s crucial indicators, and a single in Gizmodo about “vaginal wellness products” promoted on Etsy—reminded me how significantly I get pleasure from questions of meant use.  As I wrote far more about below, meant use is a vital thought in Fda regulation, in component since a product’s meant use is essential to deciding irrespective of whether it satisfies the law’s definition of drug or gadget within the FDA’s jurisdiction.  And, for no matter what purpose, I have an unabashed and—as far as I can tell—limitless love for considering by way of questions about irrespective of whether, and how, merchandise slide with the definition of a drug or gadget.

As for the documented neurotech, neuro-wearable, infant monitor, and vaginal wellness merchandise, it would seem to me that numerous of these merchandise may possibly slide within the Federal Food items, Drug, and Beauty Act’s (FDCA) definitions of medications or products.  Why is that?

The FDCA defines medications and products as merchandise “intended for use” in the prognosis, cure, mitigation, therapy, or avoidance of diseases, or “intended to have an impact on the composition or any perform of the body.”  And this definition is really wide.

The “disease” piece of the definition captures points like cancer therapies and artificial heart valves—products that match comfortably within what numerous normally recognize to be medications and products subject to Fda regulation.  But, since implicit statements about addressing condition can also bring about a solution to slide with the definition of a drug or gadget, this component of the definition also may capture points like infant displays promoted as measuring respiration and oxygen levels.  Depending on the situations, marketing a solution as monitoring a baby’s oxygen levels may possibly indicate that the solution is meant for use in preventing Sudden Infant Loss of life Syndrome (SIDS)—and that all round impression may possibly not be dispelled even if a firm disclaims its intent that the monitor be applied for preventing SIDS.  Right after all, why else monitor an seemingly healthful baby’s oxygen?

Furthermore, the “structure/function” piece of the definition signifies that the legal definition of medications and products contains not just health care treatment options but also a significantly broader class of merchandise that may possibly not be strictly “medical,” together with numerous enhancement and wellness merchandise that are meant to have an impact on the body’s composition or perform.  For case in point, a single of the firms building an implantable “neuroprosthesis” describes it as meant for “cognitive enhancement.”  As I’ve argued in the Journal of Legislation and the Biosciences, cognitive enhancement statements are very likely statements about changing—improving—the perform of the mind, which could bring about a solution to be gadget under the FDCA.  And, in fact, the company’s website offers a information tale referring to its solution as “medical gadget,” suggesting that the firm itself believes its solution to be subject to Fda oversight.  This is perhaps unsurprising, we may be expecting Fda jurisdiction around a solution designed to be implanted in the mind.  But, since the definition of a gadget turns on a product’s meant use, the exact same holds legitimate for numerous non-invasive neuro-enhancement technologies.  (Anna Wexler has an article in the Journal of Legislation and the Biosciences that offers a in-depth description of the types of statements that some non-invasive neuro-tech firms make.)

Furthermore, numerous of the vaginal wellness merchandise featured in the Gizmodo article (most of which Etsy has now eradicated, in accordance to Gizmodo), seem to be to have been accompanied by composition/perform, if not implicit or specific condition, statements.   Once more we may be expecting the merchandise promoted with statements about managing yeast or other infections to be subject to Fda oversight.  But, since the definition of medications and products contains merchandise meant to have an impact on the body’s composition or perform, the exact same holds legitimate for the parade of—seemingly terrible, at the very least to me (e.g., ground-up wasp nests for insertion into the vagina?!)—products promoted for vaginal tightening and restoring elasticity.  (Notably, these merchandise can’t be nutritional supplements—permitted to make composition/perform statements and subject to fewer Fda oversight than medications and devices—because, among other achievable explanations, nutritional nutritional supplements must be meant for ingestion, which these merchandise are not.)

Now, just since the Fda has authority around merchandise, does not imply that it will exercise that authority (see, e.g., FDA’s plan on very low-hazard, basic wellness products).   But it is even now valuable to recognize when the Fda can oversee merchandise. Particularly since, as Hank Greely tweeted, these types of merchandise may possibly spotlight a society clash among the Fda and some Silicon Valley firms (or firms that embody the Silicon Valley spirit, even if not located there) that are not applied to the concept of a gatekeeper for their merchandise.

To the extent there is a absence of knowing that the FDA’s jurisdiction extends outside of all those merchandise accompanied by explicitly “medical” statements, there is, at the very least, the potential for all those not applied to working with the company to misunderstand the scope of the FDA’s jurisdiction.

Patti Zettler is an associate professor at Georgia Condition University School of Legislation, and a CLB fellow (and SLS) alumna.