FDA Regulatory Science Lecture: The 501(k) Process
Thursday, September 26, 2013
Room 2116 Chemical and Nuclear Engineering Bldg.
Professor Keith E. Herold
Overview of the 510(K) Process
Division of Cardiovascular Devices
This lecture will cover how to obtain regulatory clearance to market devices through the substantially equivalent paradigm.
About the Speaker
Shawn Forrest has worked as a biomedical engineer lead reviewer in the Division of Cardiovascular Devices at the FDA, reviewing 510(k) and other pre-market device submissions for the past 7 years. He also previously worked for 4 years as a post-market adverse event report analyst and several months as a safety officer reviewing device recalls and manufacturer inspection reports. He has a masters of science degree in biomedical engineering from Vanderbilt University and a bachelors of science in biomedical engineering from the University of Utah.