Amanda Johnston

FDA regulatory strategy for medical products, including devices, drugs, diagnostics, and digital health technologies

Healthcare compliance, including Anti-Kickback Statute, False Claims Act, and related state laws

Compliance investigations and internal reviews

DMEPOS compliance and reimbursement-related risk management

Reimbursement support programs, including prior authorization and patient support services

Interactions with healthcare professionals, including consulting, speaker programs, and training

Promotional and educational activities, including reimbursement communications

Compliance program design, implementation, and auditing

Advises medtech, biotech, and pharma companies on structuring reimbursement support programs to mitigate fraud and abuse risk while supporting patient access

Leads and supports compliance investigations and internal reviews related to reimbursement practices, HCP interactions, and commercial activities

Develops and implements compliance programs, including policies, procedures, and training for commercial and market access teams

Evaluates consulting, speaker, and other financial arrangements with healthcare professionals for compliance with applicable laws and industry codes

Provides regulatory and compliance guidance for product launches, including promotional and reimbursement-related considerations

Conducts risk assessments and compliance audits aligned with industry standards and enforcement trends

Serves as outsourced Compliance Officer for companies across the medtech, biotech, and pharma industries, supporting ongoing compliance operations and governance

Advises on DMEPOS compliance obligations, including billing, reimbursement support, and distribution models

Amanda Johnston advises companies across the medtech, biotech, and pharma industries on FDA regulatory strategy and healthcare compliance. Clients turn to her for practical guidance on complex issues involving product commercialization, reimbursement support, interactions with healthcare professionals, compliance investigations, and risk management under federal and state fraud and abuse laws. She focuses on helping companies build compliant, scalable programs that align with business objectives while withstanding regulatory scrutiny.

Amanda’s practice is shaped by her experience working closely with commercial, market access, medical affairs, and regulatory teams. She understands how legal and compliance considerations intersect with real-world business pressures, including product launches, reimbursement challenges, and growth strategies. This perspective allows her to translate regulatory requirements into actionable frameworks that business teams can implement.

She works as an embedded advisor to in-house counsel and executive leadership, often serving in an outsourced compliance leadership role. Amanda helps clients design and operationalize compliance programs, assess risk across business activities, and develop policies, training, and controls that are tailored to their products and organizational structure.

Her work spans a range of matters, including structuring reimbursement support programs, evaluating arrangements with healthcare professionals, advising on promotional and educational activities, supporting DMEPOS compliance, and guiding internal reviews and compliance investigations. She is frequently engaged to assess high-risk or novel business models and provide clear, defensible paths forward.

Amanda is particularly focused on the intersection of FDA regulatory requirements and fraud and abuse risk, including areas where reimbursement, distribution, and patient support activities create heightened scrutiny. She brings a practical, solutions-oriented approach to helping clients move forward with confidence.

University of Minnesota Law School

J.D.

University of Minnesota – Duluth

B.A., Criminology