FDA Regulatory Science Lecture: The 501(k) Process

Thursday, September 26, 2013
4:00 p.m.
Room 2116 Chemical and Nuclear Engineering Bldg.
Professor Keith E. Herold
herold@umd.edu

Overview of the 510(K) Process

Shawn Forrest
Lead Reviewer
Division of Cardiovascular Devices
FDA

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 master’s of science degree in biomedical engineering from Vanderbilt University and a bachelor’s of science in biomedical engineering from the University of Utah.

Audience: Graduate  Faculty  Staff  Post-Docs 

 

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