Amanda Johnston, J.D., R.A.C., Managing Attorney

Email     ajohnston@gardner.law
Office    651.412.8601
Mobile   651.364.7484

Amanda Johnston, JD, RAC, Managing Attorney, Gardner Law, specializes in counseling medical technology and pharmaceutical companies on FDA law, regulatory submissions and strategy, healthcare compliance programs, and fraud and abuse laws. Amanda has worked on 100+ FDA submissions, including PMAs, 510(k)s, HDEs, IDEs, NDAs, Pre-Submissions (Q-Subs), Breakthrough Designations, De Novos, RFDs, EUAs, change control supplements, and annual reports for drugs and devices.

Prior to practicing at Gardner Law, she was the Compliance Officer at Coloplast Corp, in Regulatory Affairs at Medtronic, and in Compliance at UnitedHealth Group.

Amanda is an Adjunct Professor of Law at Mitchell Hamline School of Law where she teaches Drug & Device Law.

She has written and lectured on a variety of topics related to FDA regulatory and health care compliance. Amanda sits on the Section Council for the Minnesota State Bar Association’s Food, Drug, and Device Law Section.

101

Number of FDA Submissions Made

7

Vacations in the U.S. Virgin Islands

Amanda Johnston

My passion for FDA law was ignited when I realized, firsthand, how much of an impact medical technology has on patients and their families. I have two sisters that live with chronic diseases and conditions and rely on life-sustaining and life-saving medical devices and pharmaceuticals—one of which has endured 140+ brain surgeries and procedures and currently has 9 different implantable devices. I strive to help clients so that they can continue to make their therapies available to the patients that rely on them.
– AMANDA JOHNSTON, J.D., R.A.C.

Practice Areas:

  • Regulatory assessments and FDA submissions, including 510(k)s, De Novos, RFD’s, EUA’s, PMAs, IDEs, HDEs, NDAs, Pre-Submissions, Breakthrough Designations, change control supplements, and annual reports for drugs and devices
  • Compliance
  • Ad promo review
  • Quality
  • Clinical
  • Privacy
  • Enforcement
  • Sunshine reporting