Tricia focuses her practice on helping medical device and other life sciences companies get their products to market and maintain regulatory compliance throughout the product lifecycle.
Tricia's years working in the medical device industry in quality compliance and regulatory affairs, coupled with her legal training and experience, provides her with a unique perspective on finding creative and practical solutions to complex issues.
Committed to service and diversity, Tricia serves on the Advisory Committee for the VocalEssence WITNESS program, which celebrates the contributions of African Americans to our shared American heritage through concerts, recordings and school programs.
As a healthcare and life sciences lawyer, Tricia advises medical device, cosmetics and pharmaceutical companies on a full range of regulatory and compliance issues. Her experience at a subsidiary of a multi-national medical device company provides her with unique insight into the operational and day-to-day challenges involved in maintaining compliance while getting new products to market.
Tricia advises clients on topics on a wide-range of pre- and post-market issues including Food and Drug Administration (FDA) regulatory pathways, digital health, QSR compliance, labeling, advertising and promotional materials, medical device reporting, sales strategies, distribution, enforcement actions and recalls. Tricia also counsels clients on health care compliance issues including federal and state anti-kickback laws, Federal Trade Commission (FTC) regulation, health information privacy (HIPAA) and state licensing laws.
Tricia counsels clients regarding FDA premarket submissions.
She also advises clients regarding FDA and FTC advertising regulation.
Tricia advises digital health product companies on FDA compliance matters including mobile health applications.
She counsels medical device manufacturers regarding medical device reporting requirements and post-market surveillance processes to achieve compliance with statutory and corporate requirements.
Tricia assists clients in responding to FDA additional information requests and enforcement actions.
She works with life sciences companies to create corporate compliance programs and conducts personnel training relating to compliance issues.
She also conducts client assessments to uncover and address high risk regulatory gaps
News & Insights
- Press Release06.14.2019
- In the News12.13.2018
- Press Release07.31.2017
Drug/Device Industry Panel, MSBA FDA Forum: Current Topics and Trends, March 2019
“FDA Approval of Medical Devices,” Missouri Society of Health Care Attorneys (MSHCA) Fall Seminar, November 2018
Drug/Device Industry Panel, FDA Forum – Regulation and Litigation: Current Topics and Trends, April 2018
Co-presenter, "FDA Digital Health Updates," The Digital Health Business Series, Stinson Leonard Street in conjunction with BioKansas, February, 2018
Co-presenter, "Quality Systems Regulation and UDI," American Conference Institute's FDA Boot Camp Devices Edition, July 2017
- Speaking Engagement07.28.2017
“Revising FDA’s 510(k) Poses Challenges For Device Makers,” Law360, December 2018
Professional & Civic Activities
Professional & Civic Activities
AdvaMed's 2019 MedTech Conference, Legal and Health Care Compliance Programming Committee
Minnesota State Bar Association, Food Drug & Device Section, Council Member
The American Health Lawyers Association
Minnesota State Bar Association
Hennepin County Bar Association
Minnesota Asian Pacific American Bar Association
National Asian Pacific Bar Association
Minnesota Women Lawyers Association
Japan American Society of Minnesota
VocalEssence WITNESS, Advisory Committee
Harvard Club of Minnesota, Board of Directors
Threads Dance Project, Board of Directors
- Minnesota, 2014
- Pennsylvania, 1996
- Virginia, 1994
Harvard Law School, J.D., cum laude, 1994
- Journal of Law and Public Policy, Senior Editor
University of Virginia, B.A., with distinction, 1991