Ellen J. Flannery

Ellen Flannery is a partner and co-chair of the firm’s food and drug law practice group.  She advises clients on matters relating to regulation of medical devices, pharmaceuticals, and biological products.

Ms. Flannery’s experience includes: helping clients to develop strategic plans with respect to the appropriate premarket pathway and development plan for obtaining FDA marketing clearance or approval; advising on dispute resolution with FDA, including representing clients in Medical Devices Dispute Resolution Panel proceedings; advising companies undertaking product recalls or responding to FDA quality system inspections; advising on advertising and promotional issues; and conducting regulatory due diligence.  She also has experience with product liability, health data privacy, and antikickback laws.

Representative Matters

• Assist several early-stage companies in obtaining PMA approvals and 510(k) clearances.
• Advice in connection with FDA investigations and seizure and injunction actions.
• Representation of companies in connection with Medical Devices Dispute Resolution Panel proceedings.
• Advise companies on drug-device and biological-device combination product issues.

Honors and Rankings

• Chambers USA - America's Leading Business Lawyers, Healthcare/Pharmaceutical/Medical Products Regulatory (2008-2011)
• Named in Best Lawyers in America for work in FDA law (2007-2012).
• The International Who's Who of Life Sciences Lawyers (2012)
• Washington D.C. Super Lawyer for work in FDA law (2010-2012).
• Washingtonian, Best Lawyers (2011)
• PLC Life Sciences, Which Lawyer?, Regulatory (Medical Devices) (2005-2009) and Life Sciences (2011)
• PLC Cross-border Life Sciences Handbook for FDA regulatory work (2006-2007).
• Listed in 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.

Memberships and Affiliations

• Member, Institute of Medicine, Committee on Accelerating Rare Diseases Research and Orphan Product Development (2009-2010)
• 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; Standing Committee on the Federal Judiciary member
• Chair of the Fellows of the American Bar Foundation (2007-2008)
• American Bar Foundation Board member (2005-present)
• Boston University School of Law Board of Visitors (1995-present)
• Editorial Board member for FDA Enforcement Manual and Guide to Medical Device Regulation (1993-present)
• Member, Institute of Medicine (IOM) Committee on Postmarket Surveillance of Pediatric Medical Devices (2004-2005)

Publications and Speeches

• "Supreme Court Delivers Important Decision on Patent Eligibility," Covington E-Alert (3/23/2012), Co-Author
• "FDA Issues Draft Guidance on Evaluating Substantial Equivalence in 510(k) Premarket Notifications," Covington E-Alert (2/7/2012), Co-Author
• "FDA Issues Draft Guidance on Mobile Medical Applications," Journal of Medical Device Regulation (November 2011), Co-Author