As a recognized expert in FDA law, Suzan Onel has advised clients on regulatory, compliance, and enforcement issues for over 30 years, helping manage products throughout their lifecycles. Suzan focuses her practice on FDA and FTC issues involving medical device, food, dietary supplement, over-the-counter drug, cosmetic and consumer products. Her client base includes global, mid-sized, and start-up companies, and she regularly advises on market entry strategies, labeling and promotional activities, regulatory compliance, recalls and field corrections, and enforcement defense.
In addition to day-to-day counseling on regulatory and compliance matters, Suzan has extensive experience assisting clients with the preparation of FDA submissions including 510(k) premarket notifications, premarket approval applications (PMAs), food additive petitions, GRAS self-affirmations and notifications, food contact notifications, new dietary ingredient notifications, and adverse event reports.
Suzan advocates for her clients before the Food and Drug Administration (FDA), as well as the Federal Trade Commission (FTC), the U.S. Department of Agriculture (USDA), the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATC), the Environmental Protection Agency (EPA), the National Advertising Division of the Better Business Bureaus (NAD), and similar international and state bodies.
Suzan is also skilled at transactional work which includes conducting regulatory due diligence for food and life science companies and investors, drafting supplier contracts and clinical research agreements, and conducting executive training sessions.
Suzan is a frequent and sought after author and lecturer on FDA-related topics, including medical device software, food regulation and dietary supplement/functional food. She is also co-editor of the PLI treatise, “Medical Devices Law and Regulation Answer Book” (which has been updated regularly since 2011), was invited by the U.S. State Department to be the keynote speaker at a government-sponsored conference in Honduras on FDA Best-Practices, and has been named to Best Lawyers in America and Super Lawyers for FDA Law since 2015.
Prior to joining Kleinfeld, Kaplan & Becker, Suzan was Chair of the FDA Practice at a global law firm.
Representative matters include:
- Working with a team of outside lawyers as the lead FDA counsel for a global device company confronted with two 483s, a related warning letter, two simultaneous congressional investigations, and simultaneous enforcement investigations by the FDA and DOJ.
- Conducting internal compliance investigations, including drafting compliance programs and conducting executive training sessions.
- Developing premarket regulatory strategies.
- Drafting and advising on premarket submissions including IDE, 510(k) clearance, De Novo PMA applications, GRAS notifications, Food Additive Petitions, and New Dietary Ingredient Notifications.
- Advising on adverse event reports, product recalls and field actions, and postmarket surveillance studies.
- Reviewing labeling, advertising and various forms of social media for compliance.
- Performing regulatory due diligence and post-acquisition risk mitigation.
- Responding to FDA Form 483s, warning letters, import alerts, FDA and FTC enforcement actions and investigations, and negotiating consent decrees.
- Providing advice and guidance on the regulation of in vitro diagnostics (IVDs), laboratory developed tests (LDTs), and research use only (RUO) products.
- Assisting with post-market compliance.
Publications & Speaking Engagements
Books and Chapters
- “US FDA and the Products it Regulates,” Kirk-Othmer Encyclopedia (2019)
- Medical Devices Law and Regulation Answer Book (PLI, multiple editions), Treatise Co-Editor and Chapter Author.
- “Cosmetic Regulation Revisited,” Food and Drug Law and Regulation (FDLI 3rd Ed, 2015).
“Where the ‘App’ World and FDA Collide: Current Status of the FDA’s Regulation of Medical Device
Software and Mobile Medical Apps,” Inside the Minds – Recent Developments in Food and Drug Law
(Thomson Reuter 2014).
- FDA Withdraws Compliance Policy Guide on Homeopathic Drug Products and Issues Revised Draft Guidance, KKB FDA Alert, November 2019.
- USDA Issues Interim Final Rule on Hemp Production, KKB FDA Alert, October 2019.
- No Time Like the Present: FDA Issues Numerous Device-Specific Guidance Documents in 2018 (1-4 Installments), KKB FDA Alert, September 2018.
- Welcomed New Developments in FDA’s Regulation of Digital Health Products, KKB FDA Alert, August 2017.
- 21st Century Cures Act Provides (Some) Clarity on FDA’s Regulation of Software, FDLI Update Medical Devices Issue, March/April 2017.
- President Obama Signs Federal GMO Law, Preempts Vermont Law. Food, Drugs, Medical Devices and Cosmetics (FDA) Alert, 8 August 2016.
- The Future of Medical Device Manufacturing is Here: FDA Issues Draft Guidance on Technical Considerations for 3D Printing. Food, Drugs, Medical Devices and Cosmetics (FDA) Alert, 29 July 2016.
- How American Eat: Unveiling of the New Nutrition Facts Label. Food, Drugs, Medical Devices and Cosmetics (FDA) Alert, 21 June 2016.
- U.S. FDA Finalizes Medical Foods Guidance. Food, Drugs, Medical Devices and Cosmetics (FDA) Alert, 1 June 2016.
- Vermont Act 120 and Beyond: Genetically Engineered Food, Where Are We Now? Food, Drugs, Medical Devices and Cosmetics (FDA) Alert, 11 May 2016.
- FDA’s Evolving Policy Toward Health IT, Medical Apps, and Low Risk Devices. Food, Drugs, Medical Devices and Cosmetics (FDA) Alert, 11 March 2015.
- “Application of the 2019 Clinical Decision Support Software Draft Guidance,” Moderator, FDLI Conference on Digital Health Technology During COVID-19 and Beyond, September 10, 2020.
- “Compliance Central with FDA – Center Compliance Directors,” FDLI Enforcement, Litigation, and Compliance Conference, Moderator, Washington, D.C., December 2019.
- “International Medical Device Regulation and Harmonization,” FDLI Annual Conference, Moderator, Washington, D.C., May 2019.
- “Life Cycle of an Indie Acquisition,” ACI Cosmetic and Personal Care Products Conference, New York, NY, March 2019.
- “Joint Development of Medical Devices: Best Practices for Safeguarding Your IP and FDA Rights,” Licensing Executives Society (LES) Life Sciences Section Webinar, September 2018.
- “Development of Medical Devices: Best Practices for Safeguarding Your IP and FDA Rights,” FDLI On-Demand Webinar, November 2017.
- “Investigational Device Exemptions (IDE) and the Practice of Medicine,” Children’s Hospitals Pediatric Research Alliance, Boston, MA, October 2017.
- “Improving Commerce for Economic Growth, “Keynote Speaker at Central American regional conference on trade facilitation and best practices to improve entry of food, drugs, and medical devices into Honduras. Invited by U.S. State Department. Conference supported by the U.S. Embassy, the Foreign Agricultural Service, the U.S. Commercial Service, American Chamber of Commerce, and USAID. Tegucigalpa, Honduras. May 2017.
- “3D Printing: Regulatory, Reimbursement and Product Risk Considerations,” AdvaMed MedTech 2016 Annual Conference, Minneapolis, MN, October 2016.
- “Food Safety Modernization Act: The Future of Food Litigation,” Inter-American Law Review Symposium, University of Miami Law School, February 2015.
- “Advertising Enforcement,” FDLI Food Week 2015, Moderator, February 2015.
- “FDA’s 510(k) Premarket Notification Program: What It Is and Where It’s Going,” Center for Professional Advancement (CfPA), January 2015.
- First Annual EU Nutrition and Consumer Law Workshop Association of Corporate Counsel (Utah) and Stoel Rives, September 2014.
- FDLI Annual Conference, Moderator, Breakout Session for Medical Device Center Directors, Washington, D.C., April 2014.
- “Compliance and Liability Issues: Latest Developments,” FDLI Medical Devices Conference: Key Legal and Regulatory Developments, Washington, D.C., February 2014.
- “Best Practices by Promotional Review Teams: Ensuring Compliant and Effective Promotion,” FDLI Advertising and Promotion Conference, Washington, D.C., September 2013.
- “Eighth Annual Neurotech Investing & Partnering Conference,” NeuroInsights, San Francisco, CA, May 2013.
- “Regulation of Medical Food and Nutritionals in the European Union, China, and the United States,” K&L Gates Webinar, April 2013.
- “Health-Related Foods: Claims, Marketing, Labeling and Expectations,” 2012 RAPS Conference – The Regulatory Convergence, Seattle, WA, October 2012.
- “What Medical Device Stakeholders Are and Should Be Talking About,” FDLI Medical Device Regulation and Litigation Conference, Washington, D.C., June 2012.
- “Seventh Annual Neurotech Industry Investing and Partnering Conference,” NeuroInsights, Boston, MA, May 2012.
- “Navigating Regulatory Pathways in Neurology and Psychiatry,” Sixth Annual Neurotech Industry Investing and Partnering Conference, NeuroInsights, San Francisco, CA, May 2011.
- “Medical Device Regulatory Compliance,” 3-day Conference for CfPA, New Brunswick, NJ, April 2011.
- “FDA’s 510(k): Premarket Notification Program: What It Is and Where It’s Going,” CfPA Webinar, March 2011.
- “FDA’s MenaFlex Decision and Its Potential Impact on the Device Clearance Process,” OCTANe, Irvine, CA, February 2011.
Recognition & Professional Activities
- Listed as a “Life Science Star” by Legal Media Group (2018-2020) in its Life Sciences publication of the leading U.S. firms and attorneys for FDA Medical Devices and FDA Pharmaceutical Regulatory practices.
- Quoted in Washington Lawyer, “What are Some of the Top Trends in Food Law?” (October 2017).
- Quoted in Bloomberg Law/BNA Medical Devices Law & Industry Report, “When does Changing a Medical Device Trigger FDA Rules?” (September 13, 2017).
- Quoted in Washington Post Magazine, “The Battle over Essure” (July 30, 2017).
- Served as international expert in the areas of food, drugs, and medical devices as part of a program on trade facilitation and best practices hosted by the Government of Honduras with support by the U.S. State Department, the American Chamber of Commerce, and USAID.
- Listed in “The Best Lawyers in America” directory for FDA Law, US News and World Report, 2015-2021.
- Listed in Washington D.C. Super Lawyers, Thomson Reuters, 2015-2021
- Volunteer, Medical Reserve Corps, Fairfax Team
- Former Chair, Food, Cosmetics and Nutraceuticals Committee, ABA Section of Sciences & Technology Law (2012-2015)
- Former Co-Chair, FDLI Medical Devices Committee (2012-2015)
- Former FDA Counsel, Neurotechnology Industry Organization (NIO) (2008-2015)
- UVA Law Class Manager, Annual Giving Program, 2005-2009
- Former Chair, FDLI Update Editorial Advisory Board
- Member, Food and Drug Law Institute (FDLI) and Regulatory Affairs Professionals Society (RAPS)
B.A., University of Pennsylvania (Neurobiology and European Intellectual History, Honors)