Amanda Johnston, J.D., R.A.C., Senior Attorney
‭+1 (651) 412-8601 office
‭+1 (763) 639-6951 mobile

Amanda Johnston 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 75+ 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 a council member on the Minnesota State Bar Association – Food, Drug, and Device Law section.





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:

  • Compliance assessments, investigations and training
  • Design and implementation of compliance programs
  • Advertising and promotional review
  • Business interactions with health care professionals
  • Transparency reporting
  • Privacy compliance
  • 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

Prior to practicing at Gardner Law, she worked as a Compliance Officer at Coloplast, Corporation, in Regulatory Affairs at Medtronic and in compliance at UnitedHealth Group.

  • Minnesota State Bar Association
  • Member of the Minnesota State Bar Association Food, Drug, and Device Law Section Council

  • Juris Doctor, University of Minnesota Law School (Minneapolis, MN), concentration: Health Law and Bioethics
  • Bachelor of Arts, Criminology (Summa Cum Laude), University of Minnesota-Duluth (Duluth, MN)

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

  • Drafting countless regulatory and legal assessments regarding the compliance of promotional programs with FDA and FTC regulations, the Anti-Kickback Statute, False Claims Act, Stark Law, Sunshine Act, HIPAA, the Foreign Corrupt Practices Act, and other laws
  • Helping clients structure arrangements that facilitate compliance with Anti-Kickback Statute Safe Harbors
  • Reviewing and drafting various agreements for regulatory compliance
  • Establishing lawful Medical or Clinical Affairs-directed off-label dissemination policies and procedures for pharmaceutical and medical device manufacturers
  • Evaluating reimbursement tools and messaging for various manufacturers
  • Developing customized compliance policies and procedures for various medical device and pharmaceutical manufacturers
  • Performing privacy (HIPAA) reviews for pharmaceutical and medical device manufacturers
  • Assisting manufacturers with setting up third-party due diligence processes
  • Helping manufacturers understand the Open Payments (Physician Payments Sunshine Act) reporting process from tracking and compiling to reporting out
  • Assisting manufacturers with make decisions about potential product recalls vs. corrections and drafting customer communications
  • Creating training content and assisting with implementing training programs
  • Providing compliance training
  • Helping clients understand FDA’s UDI requirements and compliance expectations
  • Drafting FDA submissions, including 510(k)s, De Novos, PMAs, NDAs, HDEs, IDEs, and Pre-Submissions (Q-Subs)
  • Regulatory assessments and strategic discussions around change control, including drafting letter-to-file, FDA change control supplements, and annual reports for drugs and devices
  • FDA interactions and support, including Pre-Submission (Q-Sub) meetings with FDA
  • Helping companies understand FDA regulations, guidance, and expectations related to regulatory submissions
  • FDA enforcement actions

Practical Aspects of Putting a Compliance Program Together, Speaker, MedTech Monitor 2019: Industry Trends, Fox Rothschild LLP, Minneapolis, Minnesota (April 17, 2019).