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 of experience working in the medical device industry, coupled with her legal training and experience, provides her with a unique insight into the operational and day-to-day challenges involved in getting products to market and maintaining compliance with the various laws that govern the sales and distribution of life sciences products, allowing her to provide creative and practical solutions to complex problems.

As a health care and life sciences lawyer, Tricia advises medical device, cosmetics and pharmaceutical companies, and other suppliers and vendors in the health care industry, on a full range of regulatory and compliance issues including Food and Drug Administration (FDA) regulatory pathways, digital health, labeling, advertising and promotion, sales strategies, distribution, Sunshine Act reporting, FDA enforcement actions, recalls, federal and state anti-kickback laws and state licensing.

A significant amount of Tricia's practice also includes advising clients in the health care industry regarding data use, HIPAA privacy and security requirements and related matters.

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.

Experience

Tricia advises clients regarding FDA and Federal Trade Commission (FTC) advertising and labeling regulation.

She also advises clients regarding FDA and Federal Trade Commission (FTC) advertising and labeling regulation.

Tricia advises digital health and artificial intelligence product companies on FDA compliance matters including mobile health applications.

She assists health care clients to find pathways for HIPAA-compliant data use, and counsels clients regarding the HIPAA marketing rules and business associate agreements.

Tricia assists clients in responding to FDA information requests, Form 483 observations and other enforcement actions.

She counsels clients regarding FDA premarket submissions, quality system regulation requirements and FDA inspections.

Tricia drafts and reviews various types of contracts needed in the life sciences industry including agreements related to sale agents, distribution, purchasing, manufacturing and supply, non-disclosure agreements, business associate agreements and consulting agreements.

She works with life sciences companies and other vendors and suppliers in the health care industry to assess compliance gaps, create corporate compliance programs, codes of conduct, policies and procedures, and conduct personnel compliance training.

News & Insights

Speaking Engagements

"FDA Updates 2021," Stinson's Life Sciences Law Update, May 2021

Panelist, "AI in Healthcare," The National Bar Association Commercial Law Section 33rd Annual Corporate Counsel Conference, February 2020

Panelist, Stinson's Heartland GRC Data Breach Simulation, January 2020

"Digital Health Software, Does FDA Intend to Regulate It or Not?" Health Law and Food Drug & Device Law Sections, MSBA CLE, December 2019

"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

Minnesota State Bar Association

  • Food Drug & Device Law Section, Council Member

Minnesota State Bar Association

Hennepin County Bar Association

Minnesota Asian Pacific American Bar Association

National Asian Pacific Bar Association

Minnesota Women Lawyers Association

Japan America Society of Minnesota

VocalEssence WITNESS, Advisory Committee

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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