People
Elaine Tseng focuses on regulatory matters in the area of life sciences. A partner in our FDA and Life Sciences practice, Elaine represents medical device, pharmaceutical and other life sciences sector clients in a variety of regulatory strategy, approval, marketing, compliance and enforcement matters.
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.
J.D., Harvard University
B.A., Cornell University, magna cum laude
California
District of Columbia
Texas
January 1, 2019
Elaine Tseng quoted on the FDA proposing to update its process for how it clears most medical devices to be marketed in the U.S.
August 1, 2018
King & Spalding Advises Claret Medical on $270 Million Acquisition by Boston Scientific Corp.
March 11, 2021
Biden Administration - What's Ahead for the Life Sciences Industry?
February 5, 2021
FDA Appoints Renowned Cybersecurity Researcher to Head Agency's Medical Device Cybersecurity Efforts
August 17, 2020
Federal Government Takes Steps Toward Enforcement of ClinicalTrials.gov Requirements
January 1, 2019
Elaine Tseng quoted on the FDA proposing to update its process for how it clears most medical devices to be marketed in the U.S.
August 1, 2018
King & Spalding Advises Claret Medical on $270 Million Acquisition by Boston Scientific Corp.
March 11, 2021
Biden Administration - What's Ahead for the Life Sciences Industry?
February 5, 2021
FDA Appoints Renowned Cybersecurity Researcher to Head Agency's Medical Device Cybersecurity Efforts
August 17, 2020
Federal Government Takes Steps Toward Enforcement of ClinicalTrials.gov Requirements
January 1, 2019
Elaine Tseng quoted on the FDA proposing to update its process for how it clears most medical devices to be marketed in the U.S.
August 1, 2018
King & Spalding Advises Claret Medical on $270 Million Acquisition by Boston Scientific Corp.
J.D., Harvard University
B.A., Cornell University, magna cum laude
California
District of Columbia
Texas