Quynh Hoang is a senior regulatory consultant in the FDA and Life Sciences practice of King & Spalding’s Washington, D.C. office. She specializes in the FDA’s premarket process (for medical devices and combination products with a device constituent part (e.g., 513(g), 510(k), De Novo, IDE, HDE, PMA, RFD, and Reclassification Petition), as well as, in the FDA’s postmarket process for adverse signals.

Quynh joined King & Spalding in 2014 after 24 years at the FDA’s Center for Devices and Radiological Health. Her experience at the FDA included 19 years in the premarket review of cardiac, ophthalmic and neurological devices, where she served as an Electrical/Biomedical Engineer Reviewer, Chief of the Vitreoretinal and Extraocular Devices Branch, Chief of the Neurodiagnostic and Neurotherapeutic Devices Branch, and Chief of the Neurodiagnostic and Neurosurgical Devices Branch. Highlights of her accomplishments include leading the review of the first ophthalmic excimer laser systems that are the precursors of todays’ LASIK Eye Lasers and receiving recognition as the FDA’s Peer-Reviewed Expert in Laser Refractive Surgical Devices. For the neurological device area, she was a key contributor to the review policies and to the reorganization that led to the Division of Neurological and Physical Medicine Devices. She has had hands-on experience over a broad breadth of neuro devices, which included diagnostic, endovascular, stimulation and surgical devices. On the postmarket side, Quynh was an Expert Issue Manager tasked with leading teams of premarket, postmarket and communication experts in identifying the response options for the Center.