Amy Fowler, J.D., R.A.C., Consultant

Amy is a submissions expert. Amy has spent the last 26 years getting 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.  She has worked extensively on projects involving software devices, dental products, wound dressings, apps and combination products.  Amy also is an expert on UDI issues.  She can help you prepare and meet with FDA, whether it is a Pre-Submission, appeal or other critical issue.  Amy previously worked at 3M, Dentsply, Ecolab, and RCRI.

Amy is Chair of the Minnesota State Bar Association Food, Drug, and Device Section and co-teaches “Legal Basis of Regulatory Affairs” and 510(k) courses for the 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.

In her free time, Amy enjoys horseback riding, traveling, the arts and attending concerts, and spending time with her family. Amy is a decorated rider and has won various equestrian competitions.