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. 

Overview

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 health care 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.

Experience

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

Speaking Engagements

"FDA's Current Thinking Regarding Digital Health Products," Recent Developments in Health Care and Life Sciences Law Seminar, Stinson, December 2019

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

Publications

"Expert Focus: Will the Claire’s recall push the US to improve cosmetics regulation?" Chemical Watch, May 2019

Revising FDA’s 510(k) Poses Challenges For Device Makers,” Law360, December 2018

"FDA Changes MDR Rule to Allow Summary Reporting for Certain Medical Device Malfunctions," August 2018

Professional & Civic Activities

Professional & Civic Activities

AdvaMed MedTech Conference, 2019 Programming Committee

Minnesota State Bar Association

  • FDA Law Section, Chair
  • 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

Admissions

  • Minnesota, 2014
  • Pennsylvania, 1996
  • Virginia, 1994

Education

Harvard Law School, J.D., cum laude, 1994

  • Journal of Law and Public Policy, Senior Editor

University of Virginia, B.A., with distinction, 1991

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