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

· "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

· "FDA Issues Draft Guidance on Mobile Medical Applications," Covington E-Alert (8/4/2011), Co-Author

· "FDA Issues Draft Guidance Regarding Research Use Only and Investigational Use Only In Vitro Diagnostic Products," Covington E-Alert (6/13/2011), Co-Author

· "CDHR: 510(k)s and Science in Regulatory Decision-Making," Journal of Medical Device Regulation (November 2010), Co-Author

· "FDA's 510(K) Working Group Releases Preliminary Report and Recommendations," Covington E-Alert (8/10/2010), Co-Author

· "FDA Plans to Regulate Laboratory Developed Tests as Devices," Journal of Medical Device Regulation (August 2010), Co-Author

· "FDA Announces Public Meeting to Discuss Plans to Regulate Laboratory Developed Tests as Medical Devices," Covington E-Alert (6/21/2010), Co-Author

· "Summary of FDA Advertising and Promotion Enforcement Activities," Covington E-Alert (6/3/2010), Co-Author

· "Summary of FDA Advertising and Promotion Enforcement Activities," Covington E-Alert (4/28/2010), Co-Author

· "FDA Orders Submission of Data Regarding Certain Class III Pre-Amendment Medical Devices," Covington E-Alert (4/13/2009), Co-Author

· "AdvaMed Adopts Revised Code of Ethics on Interactions with Health Care Professionals," Covington E-Alert (12/23/2008), Co-Author

· "New Hampshire Prescription Data Ban Ruled Unconstitutional," Covington E-Alert (5/17/2007), Co-Author

· "CMS Issues Proposal to Revise Clinical Trial Policy National Coverage Determination," Covington E-Alert (5/3/2007), Co-Author

· "The Impact of the Deficit Reduction Act of 2005 on Pharmaceutical Manufacturers," Covington E-Alert (3/3/2006), Co-Author

· "CMS Issues Proposed Rule for the Competitive Acquisition Program," Covington E-Alert (4/5/2005), Co-Author

· "Medicare Prescription Drug Benefit: CMS Clarifies Final Rules for Medicare Prescription Drug Benefit Program," Covington E-Alert (4/4/2005), Co-Author

· "Analysis of Final Rule Implementing Medicare Part D Prescription Drug Benefit," Covington E-Alert (2/1/2005), Co-Author

· "Overview of Final Rule Implementing Medicare Part D Prescription Drug Benefit," Covington E-Alert (1/27/2005), Co-Author

· "Medicare Part D: USP Final Model Guidelines," Covington E-Alert (January 2005), Co-Author

· "Manufacturer Submission of Average Sales Price Data for Medicare Part B Drugs and Biologicals: CMS Final Rule on ASP Calculation Methodology," Covington E-Alert (9/17/2004), Co-Author

· "Medicare Part D: USP Draft Model Guidelines and Public Comment Session," Covington E-Alert (August 2004), Co-Author

· "Key Provisions of the CMS Medicare Drug Benefit Proposed Rule," Covington E-Alert (August 2004), Co-Author

· "Manufacturer Submission of Average Sales Price Data for Medicare Part B Drugs and Biologicals: CMS Interim Final Rule," Covington E-Alert (4/14/2004), Co-Author

· "Average Wholesale Price Reform Provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003," Covington E-Alert (12/11/2003), Co-Author

· "Prescription Drug Benefit Provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003," Covington E-Alert (11/26/2003), Co-Author

· "Liability Exposure for Exclusion and Inclusion of Women as Subjects in Clinical Studies," Women in Health (6/16/1994), Author

Judicial Clerkship

· Hon. David L. Bazelon, U.S. Court of Appeals, District of Columbia Circuit, 1978-1979