Amanda Johnston
Partner
O: 651.364.7484
M: 763.639.6951
Amanda Johnston advises medtech and biotech companies on FDA regulatory strategy, healthcare compliance, and fraud and abuse risk across the product life cycle. She is widely recognized for advising on complex compliance and commercialization strategies at the intersection of FDA regulation, reimbursement, and fraud and abuse law. Amanda provides practical, business-focused guidance that enables companies to pursue commercial growth while mitigating regulatory and enforcement risk.
Amanda has led enterprise compliance initiatives implementing policies, training programs, and monitoring systems addressing fraud and abuse risk, transparency reporting, promotional oversight, and reimbursement compliance. Her experience includes advising companies on CMS reimbursement requirements and related compliance considerations affecting DMEPOS suppliers and reimbursement support programs, as well as preparing and submitting Advisory Opinion requests to the Office of Inspector General.
She works closely with commercial, market access, medical affairs, and regulatory teams to structure compliant marketing, reimbursement support, and distribution models, ensuring that risk mitigation measures are embedded within business processes rather than layered on after the fact. She frequently advises on compliance investigations, corrective action planning, and remediation 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