News
FDA updates VMSRP instructions for summary MDR reporting – including reasons for possible program exclusion
07 October 2020
Senior AssociateWashington, D.C.
Email seth.olson@hoganlovells.com
Phone +1 202 637 5476
Fax +1 202 637 5910
Practice groupGlobal Regulatory
Seth Olson helps clients maneuver the U.S. Food and Drug Administration's (FDA) complex medical device and technology regulations.
As a former regulatory counsel at the Center for Devices and Radiological Health (CDRH) at FDA, Seth brings his regulatory experience to bear as he advises companies on both medical device premarket review and postmarket compliance issues.
Prior to joining Hogan Lovells, Seth also worked at an international law firm in Washington, D.C., where he concentrated on FDA regulatory matters. In addition to Seth's law degree from The George Washington University Law School, he holds a Masters of Business Administration from the University of New Hampshire and also studied biology at Brigham Young University.
Food and Drugs (Washington, D.C.), Rising Star
Super Lawyers
Education
J.D., The George Washington University Law School, 2016
M.B.A., University of New Hampshire, high honors, 2014
B.S. Biology, Brigham Young University, 2010
Bar admissions and qualifications
District of Columbia
Advised investigational immunotherapy company regarding FDA's Investigation Device Exemption requirements and applicable medical device premarket pathways.*
Advised multiple medical device companies on responding to FDA enforcement letters and facility inspection observations.*
Performed FDA regulatory review on multiple medical device and technology corporate mergers and transactions.*
*Matter handled prior to joining Hogan Lovells.
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