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Suzan Onel

Partner
+1.202.778.9134
Fax +1.202.778.9100
Ms. Onel practices FDA law with a primary focus on regulatory issues involving medical devices, foods, dietary supplements, over-the-counter drugs, cosmetics and consumer products. She regularly advises international and domestic manufacturers, distributors, and researchers on market entry strategies, labeling and promotional activities, regulatory compliance, recalls and field corrections, and enforcement defense. Ms. Onel assists 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. Ms. Onel’s experience includes representing clients before the U.S. Food and Drug Administration; the Federal Trade Commission; the U.S. Department of Agriculture; the Bureau of Alcohol, Tobacco, and Firearms; the National Advertising Division of the Better Business Bureaus; and similar international and state bodies.

Ms. Onel’s practice also includes FDA due diligence investigations and advising companies and private equity/venture capital investors on transactional matters involving life science company acquisition, divestment and capital growth as well as supplier contracts and clinical research agreements. Additionally, she counsels clients on trademark and copyright protection, unfair competition, the Lanham Act, trade dress, and Internet-related issues.

Professional Background

Ms. Onel regularly speaks and writes on FDA issues including medical device software, food regulation, and dietary supplement/functional food. She has written articles and chapters in compilations published by the Food and Drug Law Institute, the Regulatory Affairs Professionals Society, the Medical Device & Diagnostic Industry, and others. Ms. Onel is also co-editor of the PLI treatise, “Medical Devices Law and Regulation Answer Book 2014.”

Achievements

  • Included in "The Best Lawyers in America" directory for FDA Law (2015)

Professional/Civic Activities

  • Chair, K&L Gates FDA Practice Group
  • Co-Chair, K&L Gates Hiring Committee, Washington, DC Office, 2005-2009
  • Chair, Food, Cosmetics and Nutraceuticals Committee, ABA Section of Science & Technology Law
  • Co-Chair, FDLI Medical Devices Committee
  • FDA Counsel, Neurotechnology Industry Organization (NIO)
  • UVA Law Class Manager, Annual Giving Program, 2005-2009
  • Former Chair, Food and Drug Law Institute Update Editorial Advisory Board
  • Member, Food and Drug Law Institute (FDLI) and Regulatory Affairs Professionals Society (RAPS)

Speaking Engagements

  • “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, DC, 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.
  • “FDA’s MenaFlex Decision and Its Potential Impact on the Device Clearance Process,” K&L Gates Life Sciences Breakfast Briefing, Boston, MA, November 2010.
  • “Navigating Regulatory Pathways in Neurology and Psychiatry,” Fifth Annual Neurotech Industry Investing and Partnering Conference, NeuroInsights, Boston, MA, May 2010.
  • “FDA Update,” NIO Policy Tour, Washington, D.C., March 2010.
  • “Clinical Investigations: Investigational Device Exemption (IDE), Institutional Review Boards (IRBs) and Informed Consent,” FDA Commissioner’s Fellowship Program, FDA Campus, Silver Spring, MD, January 2010.
  • “FDA: Is there Any Hope?” Fourth Annual Life Science CEO Summit sponsored by Morgenthaler Ventures, San Francisco, CA, November 2009.
  • “Medical Device Regulatory Compliance,” 3-day Conference for CfPA, New Brunswick, NJ, November 2009.
  • “Clinical Investigations: Investigational Device Exemption (IDE), Institutional Review Boards (IRB’s) and Informed Consent,” FDA Commissioner’s Fellowship Program, FDA Campus, Silver Spring, MD, July 30, 2009.
  • “Navigating the Global Regulatory Market and Effective Clinical Trial Designs,” Fourth Annual Neurotech Industry Investing and Partnering Conference, NeuroInsights, San Francisco, CA, May 2009.
  • “Impact of Change in Administration on FDA,” NIO Policy Tour, Washington, DC, February 2009.
  • “Introduction to Medical Device Law and Regulation: A Program on Understanding How the Government Regulates the Medical Device Industry,” The Food and Drug Law Institute (FDLI), Washington, DC, February 26-27, 2009.
  • “How Does the CPSIA Affect FDA-Regulated Industries?” K&L Gates Webinar, January 29, 2009.
  • “Medical Device Regulatory Compliance,” 3-day conference for CfPA, New Brunswick, NJ, November 3-5, 2008.
  • “Views from the Center: Implementing the FDA AA in an Age of Rapid Scientific Advancement,” Food and Drug Law Institute (FDLI) Annual Conference, Washington, DC, March 2008.
  • “Public Policy and Neurotech,” Third Annual Neurotech Industry Investing and Partnering Conference (NeuroInsights), Boston, MA, May 2008.
  • “Medical Device Regulator Compliance,” 3-day conference for CfPA, New Brunswick, NJ, November 2007.
  • “Special Concerns for Manufacturing and Marketing Functional Foods,” ACI, San Francisco, CA, May 2007.
  • “Medical Device Regulatory Compliance,” 3-day conference for CfPA, New Brunswick, NJ, October 2006.
  • “Introduction to Medical Device Law & Regulation,” FDLI, Washington, DC, January 2006.
  • “Medical Device Regulatory Compliance,” 3-day conference for CfPA, Millbrae, CA, September 2005.
  • “Introduction to Medical Device Law & Regulation,” FDLI, Washington, DC, May 2005.
  • “Medical Device Regulatory Compliance,” 3-day conference for CfPA, Northbrook, IL, October 2004.
  • “Patent Protection for Medical Devices, Law and Strategy,” Minnesota State Bar Association, May 17, 2004.
  • “Food Allergens: Thresholds, Labeling, Manufacturing, and Consumer Issues,” 47th Annual Conference of FDLI, Washington, DC, April 16, 2004.
  • “Medical Device Regulatory Compliance,” 2-day conference at Steris Corporation, October 2, 2003.
  • “FDA Regulation of Electronic Records under Part 11,” Biotechnology Industry Organization (BIO) Annual Convention, Washington, DC, June 2003.
  • “The Role and Impact of Government Entities on Herbal Supplement Regulation and Litigation,” Mealeys’ Ephedra Litigation Conference, Pasadena, CA, April 2003.
  • “US Regulatory and Market Considerations for the Medical Device Industry,” videoconference simulcast to Austrade Australian Chamber of Commerce in Sydney and Melbourne, Washington, DC, March 2003.
  • “Medical Device Regulatory Compliance,” 3-day conference for CfPA, New Brunswick, NJ, March 2003.
  • “Introduction to Medical Device Law and Regulation,” FDLI, Washington, DC, October 2002.
  • “Overview of Dietary Supplement Labeling and Advertising Claims,” RAPS Annual Conference, Baltimore, MD, November 2001.
  • “FDA Regulation of Computer Software,” Biopharmaceutical Division of the Institute for International Research (IIR), Philadelphia, PA, March 2001.
  • “The Internet: Intellectual Property Points to Consider,” National Center for Non-Profit Law, Washington, DC, November 2000; October 1999.
  • “Dietary Supplement Claims: Current Issues,” Regulatory Affairs Professionals Society (RAPS) Annual Conference, Washington, DC, October 1999.
  • “The Regulation of Dietary Supplements,” 2-Day RAPS Conference, Washington, DC, August 1999.
  • “Medical Device Regulation,” CfPA, New Brunswick, NJ, March 1999; March 1998.
  • “Trademark and Copyright Compliance on the Internet,” Arts and Culture on the Net: Legal Issues of Fundraising and Marketing (multiple sponsors including American Association of Museums, Washington Area Lawyers for the Arts, and the Smithsonian), Washington, DC, November 1997.
  • “Sunscreens: Evaluating Ingredients, Regulatory Landscape, and New Products on the Horizon,” Global Business Research, Ltd., Philadelphia, PA, July 1997.
  • “Interacting with the FDA,” CfPA, New Brunswick, NJ, March 1995.