Elaine Tseng

Elaine Tseng

Partner, King & Spalding

Elaine Tseng is a partner with King & Spalding’s FDA & Life Sciences Practice Group in San Francisco.  She previously served as Regulatory Counsel at the U.S. Food and Drug Administration, where she received the U.S. Secretary of Health and Human Services’ Distinguished Service Award and other FDA honors. In addition to her government experience, Elaine’s advising is enriched by her in-house experience in the life sciences industry, where she served as corporate regulatory counsel under secondment at a multinational life sciences company.  Elaine has more than 15 years of experience specializing in FDA matters  with a particular focus on pre- and post-market regulatory requirements and policies applicable to medical devices and diagnostic products, including ophthalmic, orthopedic, cardiovascular, and neurovascular devices, in vitro diagnostic devices (IVDs) and laboratory developed tests (LDTs), software products, and drug/biologic/device combination products.  She also has substantial experience with FDA regulation of pharmaceuticals, including biopharmaceuticals, and tissue products (hCT/Ps).  Elaine’s practice involves proactive compliance and regulatory strategy counseling on areas ranging from clinical studies to regulatory approval and marketing compliance, including cGMP/quality systems compliance, adverse event and recall handling/reporting, and product promotion; advising on structuring business transactions and ventures to minimize regulatory risk; investigating and assessing potential regulatory compliance concerns; and representation of clients in interactions with FDA, including administrative appeals, petitions for regulatory action, and participation in FDA Advisory Committee deliberations.  In addition, Elaine has extensive experience conducting FDA regulatory due diligence assessments in connection with corporate transactions involving regulated entities.  Elaine frequently speaks and writes on topics of medical device and pharmaceutical regulation.  Her most recent presentations and publications include ones for the Food and Drug Law Institute, the Seton Hall Law Life Sciences Compliance Program, and Law360. Elaine is a member of the firm’s Associate Evaluation Committee, Lawyer Development Committee, and California Hiring Committee.  She is a graduate of Cornell University and Harvard University Law School.