Steven Tjoe

Steven Tjoe is a partner 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, compounded drugs, cell and gene therapies, and other drugs and biologics. Steven advises clients in analyzing premarket pathways, product adverse event risk profiles, product communications and marketing, and GMP compliance. Steven 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 across the medical device, drug, and biologic industries.

Recently, Steven 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.

Steven is a member of the Food and Drug Law Institute (FDLI), a member of the FDLI Webinar Programs Committee, and a former member of the New to Food and Drug Law Planning Committee.

Prior to joining Goodwin, Steven served as a regulatory counsel in the FDA’s Center for Devices and Radiological Health (CDRH). At FDA, Steven 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, Steven 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.

In 2021 and 2022, Steven was named a Rising Star in The Legal 500 United States Healthcare: Life Sciences for his work in FDA law and Steven was named a 2022 D.C. Rising Star by the National Law Journal. In 2021—2023, Steven was recognized by The Best Lawyers in America: Ones to Watch for his work in Administrative / Regulatory Law. Further, in 2021 and 2022, Steven was recognized by Thomson Reuters Super Lawyers as a Rising Star in Food & Drug Law.

Steven 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. Steven 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.

• Co-Author, “Top 5 Compliance Issues for Medtech Firms Transitioning To Data-Enabled Solutions,” MedCity News, January 27, 2023
• Co-Author, “Top 5 FDA Considerations for Medtech-Enabled Data Platforms,” MedCity News, January 24, 2023
• Co-Author, “Top 5 IP Considerations for Medtech Companies Transitioning To Data-enabled Product Solutions,” MedCity News, January 20, 2023
• Special Contributor, “Guide to Biosimilars Litigation and Regulation in the U.S., 2022-2023 ed.,” Thomson Reuters, 2022
• Moderator, “Getting Serious About Women’s Health in Medtech,” MedTech Conference, October 25, 2022
• Speaker, “Introduction to Biological Products, Including Vaccines, Biosimilars, Cell and Gene Therapies, and Other Advance Therapies,” FDLI Virtual Training Course, March 2022
• Speaker, “Dealing with Adverse Events and Other Post-Market Medical Device Problems,” FDLI/CDRH Training Course, March 2022 
• Author, “3 Key Considerations for Promoting Transparency for AI/ML-Enabled Medical Devices,” PM360, December 2021
• Co-Author, “FDA’s Updated Enforcement Policy for COVID-19 Tests: Key Takeaways for Developers of COVID-19 Laboratory Developed Tests and Manufacturers of COVID-19 Test Kits,”  Goodwin Insights, December 2021
• Special Contributor, Guide to Biosimilars Litigation and Regulation in the U.S., 2021-2022 ed., Thomson Reuters, October 2022
• Author, “Promotion of Devices Subject to the FDA’s COVID-19 Enforcement Policies,” PM360, June 2021 
• Special Contributor, “Guide to Biosimilars Litigation and Regulation in the U.S., 2020-2021 ed.,”Thomson Reuters, January 2021
• Co-Author, “Public Health Crises and FDA Scrutiny,”  PM360, March 2020
• Co-Author, “Developing Medical Products for Public Health Emergencies,”Goodwin Insights, February 2020
• Contributor, “Guide to Biosimilars Litigation and Regulation in the U.S., 2019-2020 ed.,” Thomson Reuters, November 2019
• Author, “The FDA, Marketing Claims, and Digital Health Products,” PM360, November 2019
• Author, “Marketing Laboratory Developed Tests,” PM360, July 2019