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

afowler@gardner.law
+1 (651) 430-7150  office
‭+1 (612) 356-9653  mobile

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.

27


YEARS OF WORKING WITH FDA-REGULATED PRODUCTS

6


HORSES COMPETED IN DRESSAGE AND EVENTING

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

Amy has worked in regulatory affairs roles at 3M, Ecolab, Regulatory & Clinical Research Institute, Inc. and in private practice. In her time as a lawyer, Amy has counseled hundreds of clients on regulatory matters.

  • Council member of Minnesota State Bar Association Food, Drug and Device Law Section, and former Chair
  • St. Cloud State University (St. Cloud, Minnesota) Instructor in Medical Technology Quality graduate program
  • President of the Central States Dressage and Eventing Association

  • Juris Doctor, Mitchell Hamline School of Law (St. Paul, Minnesota)
  • Bachelor of Science, Chemistry, University of Minnesota, School of Technology (Minneapolis, Minnesota)

  • Minnesota
  • Regulatory Affairs Certified (RAC) through the Regulatory Affairs Professionals Society (RAPS)

  • Providing FDA support to manufacturers
  • Pre-Submission meetings with FDA
  • Submitting 510(k)s
  • Making De Novo submissions
  • Gaining IDE approvals
  • IND submissions
  • DMF creation
  • NDA submissions
  • Appealing FDA decisions
  • CE marking
  • Gaining Canadian licensure