Sensitivity of 510(k) medical device filings to government shutdowns: a brief communication

Abstract

Abstract Government shutdowns may impose indirect regulatory costs on medical device manufacturers by disrupting FDA review processes. This study examines changes in 510(k) review durations surrounding the 2013 and 2018 U.S. government shutdowns. We identify significant increases in post-shutdown review times and distinct timing-dependent effects across shutdowns, highlighting the sensitivity of regulatory review timelines to operational disruptions and suggest that even partial shutdowns impede medical device review timelines.