Elaine H.
Tseng

Elaine primarily represents clients in matters involving the Food and Drug Administration. She provides proactive regulatory strategy and compliance counseling, including in the areas of FDA marketing clearance/approval and exemptions, clinical studies and product development, adverse event reporting, recalls, and other pre- and post-market compliance obligations. Elaine advises on managing FDA inspections, responding to FDA-483s and warning letters, interacting with FDA on compliance and product review matters, pursuing regulatory appeals and petitions and participating in FDA Advisory Committee deliberations. Elaine has extensive experience conducting FDA regulatory due diligence assessments in connection with corporate transactions, handling internal investigations involving FDA issues, and conducting audits and assessments of compliance with FDA requirements regarding quality systems/cGMP, clinical trials, and marketing and promotion. She also advises companies on structuring business transactions and ventures to minimize regulatory risk and potential compliance concerns.

Elaine has 20 years of experience with a broad range of FDA matters applicable to medical devices and diagnostic products, including ophthalmic, orthopedic, cardiovascular, and neurovascular devices, in vitro diagnostic devices and laboratory developed tests, digital health/software products and combination products. She also has substantial experience with FDA regulation of pharmaceuticals, including biopharmaceuticals, and human tissue products (HCT/Ps).

Previously, Elaine served as Regulatory Counsel at the FDA, where she received the Secretary of Health and Human Services’ Distinguished Service Award and other FDA honors. Elaine has also had in-house experience serving on loan as Corporate Regulatory Counsel at a multinational life sciences company.

Elaine frequently speaks and writes on topics of FDA regulation.