Amanda Johnston
Partner
O: 651.364.7484
M: 763.639.6951
Amanda Johnston advises medical device, pharmaceutical, and life sciences companies on FDA regulatory strategy, healthcare compliance, and fraud and abuse risk across the product life cycle. She brings substantial in-house experience overseeing FDA submissions, advertising and promotion compliance, and enterprise compliance programs for complex product portfolios. Clients value Amanda’s ability to translate regulatory requirements into practical compliance frameworks that support commercial execution while mitigating enforcement risk.
Amanda has led enterprise compliance initiatives within complex healthcare organizations, including implementation of policies, training programs, and monitoring systems designed to address fraud and abuse risk, transparency reporting, and promotional oversight. Her experience includes navigating interactions with the Office of Inspector General and other enforcement authorities.
She works closely with commercial, medical affairs, and regulatory teams to structure compliant marketing and distribution models, ensuring that risk mitigation measures are embedded within business processes rather than layered on after the fact. Amanda frequently advises on investigations, corrective action planning, and remediation efforts in response to identified compliance gaps.
Representation Experience
- 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.
Education
- Juris Doctor, University of Minnesota Law School—Concentration in Health Law & Bioethics
- Bachelor of Arts, Criminology, University of Minnesota Duluth
Bar Admissions and Qualifcations
- Minnesota
- Regulatory Affairs Certified (RAC), Regulatory Affairs Professional Society (RAPS)
Faculty Appointments
- Adjunct Professor of Law, Mitchell Hamline School of Law - Drug and Device Law
Honors and Awards
- 2024 Super Lawyer
- 2023 Rising Star, Super Lawyers
- 2023 Women in Business Honoree, Minneapolis-St. Paul Business Journal
- Star of Excellence, Medtronic