Related Experiment Video
Updated: Sep 4, 2026

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
Published on: March 17, 2023
Sensitivity of 510(k) medical device filings to government shutdowns: a brief communication
Karl L Schumacher1, Sindura Penubarthi2, Prashanth Asuri3
1Department of Bioengineering, Santa Clara University, Santa Clara, CA, USA. kschumacher2@scu.edu.
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.
Related Concept Videos
FDA Approved Drugs: Changes to Approved Drugs
Bacterial Signaling
Microbial Biosensors
Cleaning, Sterilization, and Disinfection
Cleaning
The cleaning process usually involves using water with detergents or enzymatic cleaner and removing foreign material from objects and surfaces, including organic material such as body fluids or inorganic material like soil. Cleaning is performed before high-level disinfection and sterilization because foreign materials on the cover of the devices interfere with process...
Investigation of Disease Outbreaks