Ellen Flannery advises clients on regulatory strategies and compliance for medical devices, pharmaceuticals, and biological products. She has significant experience in successfully helping clients to navigate the regulatory process, including effective approaches for working with FDA, dispute resolution within FDA, and zealous advocacy for her clients’ positions.
Ms. Flannery’s clients range from large multinational companies to development-stage companies, venture capital firms, clinical laboratories, and trade associations.
She has experience with cutting-edge technologies, including, for example, companion diagnostics, software and mobile medical apps, imaging devices, combination products, and humanitarian use devices. She has successfully helped clients to: develop strategic plans for obtaining FDA marketing clearance or approval; appeal from adverse determinations in IDE and 510(k) contexts; respond to FDA quality system inspections, including 483s and warning letters; and undertake product recalls. She has experience with CLIA waiver applications and laboratory-developed tests. She advises clients on postmarket reporting requirements, and advertising and promotional issues.
Ms. Flannery has served on Institute of Medicine committees that studied medical device and orphan drug matters, taught food and drug law seminars at three law schools, and regularly publishes and presents on regulatory developments. She is Co-Editor-in-Chief of Covington’s InsideMedicalDevices blog.