Overview
Gospel Justice
Whenever Brad gets free time, he loves to meet and photograph people who serve others. Over the last few years, he has been focused on the "Gospel Justice Story Project," through which he collects and reports stories on what Christian legal aid attorneys do. He has also contributed to the Gospel Justice Initiative blog, "Do Likewise."
He released his first multimedia film in July 2013, entitled "Gospel Justice: The Guardian," and wrote and photographed Christians at work serving others for a book called Macedonia, Indiana.
Focus Areas
Services
- Behavioral Health
- Corporate Compliance Program Development, Implementation, and Effectiveness
- Digital Health
- Drug and Medical Device Coding, Coverage, and Payment
- Drug and Medical Device Distribution
- FDA Inspections and Enforcement
- Health Care
- Health Policy and Legislation
- Industry Research and Clinical Trials
- Internet of Things (IoT)
- Life Sciences
- Life Sciences Due Diligence
- Product Marketing and Compliance
- Regulatory Strategy, Product Development, and Product Approvals
Experience
Recognition
- The Best Lawyers in America©, FDA Law (2015 to 2024)
- Martindale-Hubbell, "AV Preeminent" Peer Review Rating
- Washington, DC, Super Lawyers, Food and Drugs, Administrative Law, and Health Care (2013 to 2023)
- Chambers USA: America’s Leading Lawyers for Business, Leader in District of Columbia, Healthcare: Pharmaceutical/Medical Products Regulatory (2010 to 2017)
Bradley Merrill Thompson is an "extremely astute and experienced regulatory lawyer" who is "knowledgeable, articulate and passionate" about FDA regulatory issues. He is also well versed in reimbursement and adept at handling matters relating to clinical trials.
— Chambers USA
- The Legal 500 United States, Life Sciences (2014)
- American Bar Foundation, elected Fellow (2009)
- Indiana Super Lawyers (2004 to 2006)
- Medical Device & Diagnostics Industry, 100 Notable People in the Medical Device Industry (June 2004)
Credentials
Education
- University of Michigan School of Information (M.A.D.S., 2022)
- University of Michigan Law School (J.D., cum laude, 1986)
- University of Illinois at Urbana-Champaign (M.B.A., 1983)
- University of Illinois at Urbana-Champaign (B.A., cum laude, 1981)
- Major: Mathematical Economics
Bar Admissions
- District of Columbia
- Indiana
Court Admissions
- Supreme Court of the United States
- U.S. Court of Appeals for the Seventh Circuit
Board of Directors
- AquaMatic DISC, Inc. (1990-97)
- AquaMatic, Inc. (1988-97)
- EBG Advisors, Inc. (Chairman, 2015-present)
- Gospel Justice Initiative (2012-2015)
- HealthNet, Inc. (1990-94)
- Indiana Health Industry Forum (Secretary and General Counsel, 1993-2007)
- Indiana Medical Device Manufacturers Council, Inc. (Secretary and General Counsel, 1991-2006)
- Indianapolis Ambassadors, Inc. (Secretary, 1988-89)
Board of Advisors
- Medical Device Committee of FDLI
- PharmaMedDevice Conference, Reed Exhibitions
Board of Editors
- BNA's Medical Device Law & Industry Report (2007-present)
- Food & Drug Law Journal (2007-2011)
- Law360's Life Sciences Editorial Advisory Board (2014-2015)
- Medical Device & Diagnostic Industry, Santa Monica, CA (1993-2017)
- Regulatory Affairs, Rockville, MD (1991-1995)
Professional & Community Involvement
- American Bar Association
- American Bar Foundation, Fellow
- American Health Lawyers Association
- Food and Drug Law Institute
- Regulatory Affairs Professional Society
- Various positions in the Crossroads of America Council, Boy Scouts of America (1986-1995)
Events
Past Events
- August 25, 2022
- June 14, 2022
- June 9, 2022
Media
Publications
Insights
Insights
- BlogsUnpacking Averages: Analyzing FDA Device-Related Citizens Petitions by Topic10 minute read
- BlogsUnpacking Averages: Sample Size for Clinical Trials Used to Obtain FDA Medical Device Clearance13 minute read
- PublicationsUnpacking Averages: Searching for Bias in Word Embeddings Trained on Food and Drug Administration Regulatory Documents ...January–February 20242 minute read
- BlogsWhite House Executive Order on Artificial Intelligence: Implications for the Health Care and Life Sciences Industries ...6 minute read
- Media CoverageBradley Merrill Thompson Quoted in “AI vs. the Health Bureaucracy”3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “The Problem with FDA's Warning to Abiomed”5 minute read
- Media CoverageBradley Merrill Thompson Quoted in “AI Has Arrived in Your Doctor’s Office. Washington Doesn’t Know What to Do About ...4 minute read
- PublicationsNavigating the Medtech GenAI Journey: A Policy Primer2 minute read
- PublicationsWhat GCs Need to Know About Algorithmic Bias3 minute read
- BlogsUnpacking Averages: FDA’s Extraordinary Delay in Resolving Citizen Petitions17 minute read
- PublicationsA Topic-Based Analysis of FDA Responses to FOIA Requests1 minute read
- BlogsUnpacking Averages: How Accurate Do Class II Medical Devices Need to Be to Obtain 510(k) Clearance?13 minute read
- Firm Announcements
Epstein Becker Green Attorneys Recognized by 2024 Best Lawyers for Excellence in the Legal Profession
12 minute read - Media CoverageBradley Merrill Thompson Quoted in “More FDA Guidance Needed to Untangle Combination Product Regulations”2 minute read
- BlogsFDA Oversight of AI Software Developed by Health Care Providers23 minute read
- BlogsUnpacking Averages: Analyzing the Relationship Between MDRs and Recalls21 minute read
- Media CoverageEpstein Becker Green Forms Collaboration with Data, Social Scientists for AI Consulting5 minute read
- Firm AnnouncementsEpstein Becker Green and Affiliate Consultancy EBG Advisors Expand AI Advisory Capabilities Backed by Nearly 1,000 ...5 minute read
- BlogsUnpacking Averages: Searching for Bias in Word Embeddings Trained on FDA Regulatory Documents17 minute read
- Media CoverageBradley Merrill Thompson Quoted in “AI: US and EU Policymakers Move to Regulate After Industry Rings Alarm Bells” ...2 minute read
- PublicationsWhat the Data Says About FDA Responses to FOIA Requests2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA, Industry Coalition Still at Odds Over September 2022 CDS Final Guidance” ...2 minute read
- BlogsUnpacking Averages: Understanding the Potential for Bias in a Sepsis Prediction Algorithm, a Case Study29 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Ready or Not, AI Chatbots Are Coming to Hospitals”3 minute read
- BlogsUnpacking Averages: Success Rates for FDA FOIAs by Topic and Requester8 minute read
- PublicationsWhy a Data Scientist Needs a Lawyer to Correct Algorithmic Discrimination4 minute read
- Firm Announcements
Thirteen Epstein Becker Green Attorneys Named to the 2023 Washington, DC, Super Lawyers and Rising Stars Lists
4 minute read - BlogsUnpacking Averages: FDA FOIA Response Times by Topic of Request17 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Draft Guidance Allows AI/ML Devices to Evolve Without Requiring New ...5 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Draft Guidance for AI Change Control Shifts Workload to Initial Premarket ...1 minute read
- PublicationsBradley Merrill Thompson Quoted in “FDA’s Human Factors Draft Draws Fire for Introduction of ‘Critical Task’ ...2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Outlines Plan for Digital Health Technologies for Clinical Trials”4 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Growth of AI in Mental Health Raises Fears of Its Ability to Run Wild”4 minute read
- BlogsUnpacking Averages: Exploring New Data on FDA Responses to FOIA Requests14 minute read
- Media CoverageBradley Merrill Thompson Quoted in “The FDA Plans to Regulate Far More AI Tools as Devices. The Industry Won’t Go Down ...2 minute read
- Media CoverageBradley Merrill Thompson Discusses FDA Regulatory Hurdles for Breakthrough Devices2 minute read
- Media CoverageBradley Merrill Thompson and the CDS Coalition Request FDA Rescind Final Decision Support Guidance2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Why Congress Quietly Just Gave the FDA More Power”3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Industry Group Petitions FDA to Withdraw CDS Guidance”5 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Trade Group Pushes Back on FDA’s Clinical Decision Support Guidance”3 minute read
- BlogsUnpacking Averages: Using NLP to Assess FDA’s Compliance with Notice and Comment in Guidance Development18 minute read
- Media CoverageBradley Merrill Thompson Quoted in “NIST Releases New AI Risk Management Framework for ‘Trustworthy’ AI” ...3 minute read
- Media CoverageJames Boiani, Bradley Merrill Thompson Quoted in “And Over at FDA …”2 minute read
- BlogsUnpacking Averages: Creating an Industry-Specific Index to Track the FDA Regulatory Environment9 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Outlook 2023: The Regulatory Path Ahead”2 minute read
- BlogsUnpacking Averages: The Difference Between Data and the Truth: Comparing FDA’s UDI Database with FDA’s 510(k) Database ...9 minute read
- Media CoverageBradley Merrill Thompson Discusses “The Impact of Clinical Decision Support Software on the Healthcare Industry” ...2 minute read
- BlogsUnpacking Averages: Finding Medical Device Predicates Without Using FDA’s 510(k) Database5 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Torres Says Regulatory Alignment a Pressing Consideration for AI Change Control ...2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Software to Predict Risk of Sepsis, Stroke Should Be Regulated as a Medical Device ...4 minute read