Veronica Downen is a former FDA medical device reviewer with 6 years of experience in regulatory affairs. Veronica has worked on a wide range of products through hundreds of FDA reviews and numerous engagements at MCRA, including orthopedic, general hospital, cardiovascular, neurologic, and physical medicine devices, as well as antimicrobial devices, drugs, and combination products.
Veronica received her B.S. from the University of North Carolina at Chapel Hill in Applied Science with a concentration in Biomedical Engineering. Veronica also received an MS in Health Sciences from George Washington University, concentrated in Global Regulatory Affairs. Veronica is RAC-certified and actively participates in the Regulatory Affairs Professional Society within the DC area.
Previously, Veronica spent 3 years at FDA in the Center for Devices and Radiological Health (CDRH), primarily as a device premarket lead reviewer. Veronica developed a focus in combination product reviews and biocompatibility. In her last year at FDA, Veronica was selected for a pilot program where she was trained in post-market compliance and post-market surveillance review activities to help facilitate the Total Product Life Cycle reorganization of CDRH.
Overview
At MCRA, Veronica leads and supports regulatory projects from regulatory strategy assessments through full submission writing and communications with FDA. These engagements have helped MCRA clients to avoid numerous unnecessary or burdensome processes and have helped streamline costs and timelines on a broad scope of projects. Veronica has led or supported projects including regulatory landscape and strategy assessments, 510(k)s, Pre-Submissions, De Novo 510(k)s, Investigational Device Exemptions (IDE), Premarket Approval (PMA)s, and Supervisory Appeals, as well as Investigational New Drug Submissions for drugs, biologics, and combination products.