Ellen J Flannery

Ellen Flannery is co-chair of the firm’s global food and drug law practice group. She 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. REPRESENTATIVE MATTERS Assist several early-stage companies in obtaining PMA approvals, 510(k) clearances, and de novo reclassification. Assist companies in obtaining FDA approval for clinical trials of devices. Assist companies in obtaining orphan drug designation, humanitarian use designation, and humanitarian device exemption. Represent companies in securing 513(g) opinions and requests for designation. Represent companies in FDA investigations and seizure and injunction actions. Assist companies in successfully resolving disputes with FDA, including representation in connection with Medical Devices Dispute Resolution Panel proceedings. Represent companies in conducting global regulatory due diligence in potential acquisitions, investments, and other transactions. . Advise clients on legislative matters, including in connection with the medical device amendments enacted in the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA). HONORS AND RANKINGS Chambers USA - America's Leading Business Lawyers, Healthcare: Pharmaceutical/Medical Products Regulatory (2008-2012) Named in Best Lawyers in America for work in FDA law (2007-2013). The International Who's Who of Life Sciences Lawyers (2012) Washington D.C. Super Lawyer for work in FDA law (2010-2013). LMG Life Sciences, “Life Science Star” (2012) Washingtonian, Best Lawyers (2011) PLC Life Sciences, Which Lawyer?, Regulatory (Medical Devices) (2005-2012) PLC Cross-border Life Sciences Handbook for FDA regulatory work (2006-2007). Listed in Who's Who Legal, Who's Who in the World, Who’s Who in America, Who’s Who of American Women, and Who’s Who in American Law PRO BONO Coordinated team of firm lawyers in preparing a Lawyer Intake Manual for 2005 Hurricane Evacuees. Lead counsel in In the Matter of Baby “K”, 16 F.3d 590 (4th Cir. 1994). MEMBERSHIPS AND AFFILIATIONS American Bar Association, House of Delegates member; Chair of the Conference of Section and Division Delegates; Officer of the Section of Science & Technology Law; member of Health Law Section and TIPS. American Bar Association Standing Committee on the Federal Judiciary, Federal Circuit representative (2011 to present) Chair of the Fellows of the American Bar Foundation (2007-2008) American Bar Foundation Board, Secretary and member (2005-present) Boston University School of Law Dean’s Advisory Board (1995-present) Editorial Board member for FDA Enforcement Manual and Guide to Medical Device Regulation (1993-present) Member, Institute of Medicine (IOM), Committee on Accelerating Rare Diseases Research and Orphan Product Development (2009-2010) Member, Institute of Medicine (IOM) Committee on Postmarket Surveillance of Pediatric Medical Devices (2004-2005)