Photo of Sonali P. Gunawardhana


LL.M., American University Washington College of Law

J.D., University of New Hampshire School of Law

M.P.H., Boston University

M.A., Webster University

B.A., Syracuse University

Certificate in Business Administration, Georgetown University

Bar and Court Admissions

District of Columbia Bar

Maryland Bar

New York Bar

Supreme Court of the United States

U.S. District Court for the District of Maryland

Sonali draws on her nearly 10 years’ experience as an attorney at the U.S. Food and Drug Administration (FDA) to offer clients detailed and practical guidance on how to avoid and resolve FDA regulatory challenges. She imparts to clients her deep knowledge of the law and a keen forward-looking sense of how the agency will view a matter, so that the client can develop the most effective and persuasive approach in any given situation. Sonali also serves as a co-chair of Wiley Rein’s Minority Lawyers Affinity Group.

Representative Experience

Sonali's practice focuses on:

  • The rapidly changing FDA regulatory requirements for bringing medical devices to market;
  • The complex emerging rules applicable to domestic and foreign food manufacturers, suppliers, and importers;
  • Clinical trial compliance requirements for drug and medical device studies; and
  • The defense of FDA enforcement actions against drug, device, food, and dietary supplement companies, Clinical Research Organizations (CROs), academic medical research institutions, and individual researchers.

Medical Devices:

  • Counsels clients on the FDA regulatory system for the review and authorization of medical devices, drawing on firsthand knowledge of the complexities and impacts of the Agency's informal and often unwritten policies and practices.
  • Counsels clients on the regulatory process, on how best to respond to enforcement actions, and strategies for submission of comments on proposed rulemaking.
  • Experienced in the FDA regulation of medical devices, having served more than seven years at the Center for Devices and Radiological Health (CDRH) where she served as manager of the CDRH's Application Integrity Policy (AIP) Program and as the Integrity Officer for the Division of Bioresearch Monitoring.
  • At the CDRH, coordinated the review and approval of Guidance documents; exercised supervisory review of all proposed Warning Letters, Untitled Letters, and AIP enforcement actions against medical device sponsors, clinical investigators, good clinical laboratories, and the Institutional Review Boards; and initiated enforcement recommendations with respect to advertising and promotional practices for marketed and investigational devices.

Food Safety Regulation:

  • Works with food/pet food companies and associations on issues such as safety, nutrition and health, labeling, good manufacturing practice (GMP), packaging, biotechnology, and the use of risk assessment and risk management in the regulation of the safety of food components.
  • Served in the FDA's Center for Food Safety and Applied Nutrition (CFSAN), where she was immersed in numerous aspects of food safety policy and regulatory implementation related to the recently enacted Food Safety Modernization Act (FSMA).
  • Served as the lead regulatory counsel and regulation writer on both the Sanitary Food Transportation Act Proposed Rule and the Product Tracing Proposed Rule as required by FSMA.


  • Works with pharmaceutical companies on a myriad of issues including pre-submission materials, responses to the FDA during the review cycle, and regulatory actions.
  • During her tenure at the FDA, served several special duty assignments in the Center for Drug Evaluation and Research (CDER), including in the Office of Compliance and the Office of Medical Policy.

Dietary Supplements:

  • Assists clients with complex issues including the interpretation of the statutory definition of "dietary supplement," the application of the "new dietary ingredient" criteria, permitted "structure or function" claims, and impermissible "disease" claims.
  • Also counsels clients on general labeling issues, GMP compliance, as well as the distinction between labeling and advertising.
  • During her tenure with the FDA, worked closely with the Office of Nutrition, Labeling, and Dietary Supplements in ushering through the New Dietary Ingredients Draft Guidance as required by FSMA.  

Clinical Trial Compliance:

  • Counsels clients on strategies for the best course of action when regulatory correspondence is issued by the FDA, based on her capacity as Regulatory Counsel for the Division of Bioresearch Monitoring.
  • Worked closely with medical device companies and their counsel to address issues of noncompliance by submission of adequate corrective action plans.

FDA Enforcement Defense:

  • Counsels clients with all facets of FDA inspections including product recalls and enforcement actions before the FDA.
  • Sonali is very knowledgeable about the different current Good Manufacturing Practices (cGMP) and clinical trial compliance strategies and programs that the FDA field investigators use during inspections, having worked very closely with the various FDA District Offices that are responsible for conducting inspections of medical device manufacturers, institutional review boards (IRBs), clinical investigators, and contract research organizations.

Professional Experience

  • U.S. Food and Drug Administration
    • Acting Supervisory Regulatory Counsel, Center for Food Safety and Applied Nutrition, Office of Regulations, Policy and Social Sciences (2010-2012)
    • Regulatory Counsel/Integrity Officer, Center for Devices and Radiological Health, Office of Compliance, Division of Bioresearch Monitoring (2003-2010)
  • Attorney Advisor, U.S. Department of Commerce, Patent and Trademark Office (2000-2002)


  • American Bar Association (ABA), Administrative Law & Regulatory Practice Section
  • Bloomberg/BNA
    • Medical Devices Law & Industry Report Advisory Committee
  • Food and Drug Law Institute (FDLI)
    • Academic Programs Committee (2012-2015)

    • Global Committee (2013-2015)

    • Medical Device Committee (2015-2018)

  • Maryland State Bar Association


  • Named a "Life Sciences Star" for regulatory work in Euromoney's LMG Life Sciences (2016)
  • Named a "Life Sciences Star" for outstanding FDA work in Euromoney's LMG Life Sciences (2015)

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