Document Type
Article
Publication Date
2024
Abstract
Innovations in medical device technology hold the potential to improve health outcomes across the populace. Nearly half of all medical devices that enter the U.S. market each year are regulated by the Food and Drug Administration (FDA) under the 510(k) pathway. If FDA regulation of 510(k) devices stifles innovation, health outcomes will suffer over time because beneficial devices would not reach patients; on the other hand, if regulation facilitates innovation, health outcomes could improve. Most discussions of innovation under the 510(k) pathway have been either excessively reductionist (such as claims that the pathway stifles innovation) or wholly pessimistic (notably, the Institute of Medicine’s conclusion that empirical study of the pathway would not be worth the time, effort, and money involved). Unfortunately, we lack an empirically grounded understanding of how innovation occurs in devices regulated by FDA under the 510(k) pathway, and how FDA regulation worsens or improves health outcomes through its effects on innovation. This Article applies the “regulatory ancestry” methodology to study innovation in one 510(k) technology space: devices that are used to remove blood clots from the arteries of patients experiencing acute strokes. The study demonstrates that innovation in 510(k) devices occurs in more complex, nuanced ways than existing criticisms have captured. On the surface, competition between device manufacturers appears to be robust, but on closer inspection that competition may be far more limited. Incremental innovation, in which existing devices are modified in relatively limited ways, occurs frequently, but much of this activity involves the combination of existing technologies, as opposed to the incorporation of new technologies. And FDA may be able to strongly channel the direction of innovation through routine administrative decisions, without the need for rulemaking or other formal procedures. These and other useful insights and testable hypotheses concerning the effect of FDA regulation on 510(k) device innovation can be gained by using the methodologies adopted in the pilot study presented here. Considering the profound potential for device regulation under the 510(k) pathway to stifle or facilitate innovation, and thus to impact health outcomes, this Article offers a roadmap for a much-need large scale study that would help to develop a robust, empirically grounded understanding of innovation under 510(k) regulation.
Publication Title
Minnesota Journal of Law, Science & Technology
Volume
25
First Page
73
Recommended Citation
Horvath, George, "Empirically Assessing 510(k) Device Safety" (2024). Akron Law Faculty Publications. 254.
https://ideaexchange.uakron.edu/ua_law_publications/254
