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Sevan Oungoulian, PhD

General Engineer
US Food and Drug Administration
Orinda, California

Sevan Oungoulian, PhD, is a Lead Reviewer in the Peripheral Interventional Devices Team (PIDT) in the Division of Cardiovascular Devices at the US Food and Drug Administration (FDA). PIDT is responsible for reviewing regulatory submissions to support clinical trials and marketing for devices to treat peripheral cardiovascular disease.

Sevan has experience in both industry device development and government regulatory work. He previously worked in industry as a research and development engineer on embolization devices and drug-coated combination products before starting at FDA in 2018. He now serves as a lead reviewer, technical and regulatory expert at FDA where he has led or participated in regulatory reviews of Investigational Device Exemptions (IDE) and Premarket Approvals (PMA). Sevan also serves as a FDA liason to working groups for interventional device related international standards.

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