Amanda Johnston is a distinguished FDA attorney with expertise in counseling medical device and pharmaceutical companies on FDA law, regulatory submissions, healthcare compliance programs, and healthcare fraud and abuse laws. With an impressive background spanning several in-house legal, regulatory, and compliance roles within the medical device industry, Amanda brings an exceptional understanding of business and industry dynamics to her practice. Her extensive experience includes serving as interim compliance officer at a global medical device company, overseeing 130+ FDA submissions, compliance program implementation, and helping commercial teams navigate healthcare fraud and abuse laws.
Known for her approachable demeanor and unwavering dedication, Amanda is a sought-after legal advisor who combines her extensive knowledge with a practical approach. Her keen attention to detail and responsiveness ensures clients receive actionable legal advice tailored to their needs. Amanda's blend of legal prowess, industry acumen, and genuine passion for her work sets her apart as an attorney who not only comprehends the intricate regulatory landscape but also excels at translating it into pragmatic strategies that drive business forward.
- Advises on commercial programs compliance per FDA and FTC regulations, fraud and abuse laws such as the Anti-Kickback Statute, False Claims Act, and the Sunshine Act, while aiding companies in creating compliant program structures to mitigate risks.
- Assessing and auditing compliance programs, implementing and updating policies and training, and establishing compliance risk assessment programs.
- Extensive experience with FDA submissions (510(k)s, De Novos, PMAs, NDAs, HDEs, and IDEs, Q-Subs), regulatory strategy, FDA interactions, compliance guidance, and managing FDA enforcement actions and recalls.
- Juris Doctor, University of Minnesota Law School—Concentration in Health Law & Bioethics
- Bachelor of Arts, Criminology, University of Minnesota Duluth
Bar Admissions and Qualifcations
- Regulatory Affairs Certified (RAC), Regulatory Affairs Professional Society (RAPS)
- Adjunct Professor of Law, Mitchell Hamline School of Law - Drug and Device Law
Honors and Awards
- 2023 Rising Star, Super Lawyers
- 2023 Women in Business Honoree, Minneapolis-St. Paul Business Journal
- Star of Excellence, Medtronic