Amy Fowler, RAC, JD
Amy Fowler brings over 25 years of experience of guiding medical devices and pharmaceuticals to market. She counsels clients on regulatory strategies and prepares Pre-Submission, 510(k), De Novo, IDE, IND, DMF, and NDA submissions. She also helps device clients with CE marking and Canadian licenses. Her practice includes a number of projects involving software devices, dental products, wound dressings, apps and combination products. Amy also serves as an expert for US and EU UDI issues. She can help your company prepare and meet with FDA, whether it is a Pre-Submission, appeal or other critical issue. Amy is Chair of the Minnesota State Bar Association Food, Drug, and Device Section and co-teaches the “Legal Basis of Regulatory Affairs” course at St. Cloud State University. She earned her Bachelor of Chemistry from the University of Minnesota and her Juris Doctor from Mitchell-Hamline School of Law.