EMPIRICALLY ASSESSING 510(K) DEVICE SAFETY

• Published in: Jurimetrics (Chicago, Ill.) Vol. 63; no. 2; pp. 113 - 168
• Main Author: Horvath, George
• Format: Journal Article
• Language: English
• Published: Chicago American Bar Association 01.01.2023
• Subjects: Beds; Criticism; Federal regulation; Hypotheses; Medical device industry; Medical equipment; Medical technology; Medicine; Pilot projects; Quantitative analysis; Reforms; Safety; Visualization; United States > US
• ISSN: 0897-1277; 2154-4344

Most medical devices that reach the U.S. market are cleared by the FDA through the 510(k) pathway. This pathway has been repeatedly subjected to a general criticism, that it fails to ensure device safety. Critics have also identified specific statutory and regulatory provisions and specific FDA implementation practices that they claim compromise device safety. Based on these criticisms, many have proposed reforms that would dramatically alter or even eliminate the 510(k) pathway and upend the entire medical device regulatory regime. However, the empirical evidence that supports these criticisms and reform proposals is woefully limited. Indeed, the Institute of Medicine (IoM) concluded in 2011 that empirical study of the 510(k) pathway would be cost-prohibitive and unlikely to yield substantial benefits. This Article challenges the IoM's conclusions by demonstrating that empirical analysis can be used to assess many of the criticisms of the 510(k) pathway and to inform future reform proposals. The Article presents a pilot study of 510(k) clearances in a limited cohort of medical devices, combining the "regulatory ancestry" methodology that has been developed by medical scholars with quantitative analysis and network science visualization to analyze a set of medical devices in one technology space. The study demonstrates that these methodologies can provide reliable and useful information about how the 510(k) pathway functions to ensure medical device safety. The study supports the general criticism of the pathway regarding safety, finding that more than 10% of devices in the cohort were unsafe. The study also suggests that criticisms of some specific aspects of the pathway may have a solid basis, while failing to provide support for many other criticisms. Given the disruptive potential of many of the reforms that have been proposed, the study presented here provides a justification and a roadmap for a largescale empirical study of the 510(k) pathway.