United States Nuclear Regulatory Commission

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

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...

Investigating a real-time adaptive procedure system

Procedural issues are significant contributors to incidents in high-risk industries, yet current procedures fail to accommodate the gap between how work is prescribed and how it is actually performed. This study investigates the feasibility of developing a Real-Time Adaptive Proc...