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

Email     afowler@gardner.law
Office    651.430.7150
Mobile   612.356.9653

Amy Fowler brings over 25 years of experience and counsels clients on regulatory strategies and FDA support for Pre-Submission, 510(k), De Novo, IDE, IND, DMF, NDA submissions and appeals as well as helping device clients with CE marking and Canadian licenses. She has worked in regulatory affairs roles at 3M, Ecolab, Regulatory & Clinical Research Institute, Inc. and in private practice. Amy co-teaches the “Legal Basis of Regulatory Affairs” course at St. Cloud State University. Amy is also a counsel member of MSBA, FDD and a former chair.

Years of Working With FDA-Regulated Products

Horses Competed in Dressage and Eventing

Amy Fowler

I worked in regulatory affairs for almost 15 years before going back to school and becoming an attorney. I knew that as counsel I would have more tools to help my clients succeed in a regulatory environment where companies are challenged by regulations and agencies all the time. Sometimes these challenges are unfair and not based in law. Being a strong advocate for companies that bring medical technology to people in need fuels my passion for work every day.
– AMY FOWLER, R.A.C., J.D.

Practice Areas:

  • FDA support
  • Pre-Submission
  • 510(k)
  • De Novo
  • IDE
  • IND
  • DMF
  • NDA submissions
  • Appeals
  • CE marking
  • Canadian licenses