Steven Tjoe is an associate in the firm’s Technology and Life Sciences groups and a member of the firm’s FDA practice. He focuses his practice on product development strategies and regulatory compliance counseling, in particular as related to medical devices, digital health products, in vitro diagnostics, laboratory developed tests, drugs and biologics. Mr. Tjoe advises clients in analyzing premarket pathways, product adverse event risk profiles, product communications and marketing, and GMP compliance. Mr. Tjoe also advises on Hatch-Waxman patent listing and exclusivity issues, is a contributor to Goodwin’s Guide to Biosimilars Litigation and Regulation in the U.S, and regularly conducts risk analyses for offerings and transactions involving FDA-regulated entities.

Recently, Mr. Tjoe has brought his experience as former regulatory counsel at FDA to help in vitro diagnostic, laboratory developed test, digital health developer, and non-traditional medical device manufacturer clients launching critical diagnostic and therapeutic products in response to the COVID-19 public health emergency maneuver FDA’s complex and evolving medical device and technology regulations and policies.

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Professional Activities

Mr. Tjoe is a member of the Food and Drug Law Institute (FDLI), and a member of the FDLI New to Food and Drug Law Group Planning Committee.

Professional Experience

Prior to joining Goodwin, Mr. Tjoe served as a regulatory counsel in the FDA’s Center for Devices and Radiological Health (CDRH). At FDA, Mr. Tjoe advised premarket review teams and senior management on regulatory issues arising from premarket review and classification, provided counsel and strategic advice on agency enforcement actions, and advised agency officials on issues related to the development and implementation of agency regulatory policies and regulations and the application of legislation impacting FDA regulation. He was responsible for providing counsel on a variety of regulatory matters across multiple sectors, particularly in the evolving fields of precision medicine and digital health. In recent years, Mr. Tjoe was lead regulatory counsel for FDA’s Office of In Vitro Diagnostics and Radiological Health (now Office of Health Technology 7) on numerous issues pertaining to the regulation of genetic testing, companion diagnostics, and laboratory developed tests.

Recognition

Mr. Tjoe has been consistently recognized for his public service, including multiple FDA Commissioner’s Special Citations and CDRH Excellence Awards for his role in guidance, policy, and regulation development, legislation, and compliance and enforcement. Mr. Tjoe has received multiple recognition awards for his role in the development of a policy framework for oversight of laboratory developed tests, was named the CDRH employee of the month in recognition for excellence in inventing and drafting a pathway to market for the first direct to consumer laboratory developed test, and received the CDRH Center Director’s Award of Excellence in recognition of the counsel he provided to the agency on novel regulatory issues.

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Education

J.D., 2013
Antonin Scalia Law School, George Mason University
M.S., 2012
Case Western Reserve University
B.A., 2006
Duke University

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New York
Virginia
District of Columbia
U.S. Patent and Trademark Office (USPTO)
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