O'Donnell, Edward J.

Mr. O'Flaherty is a principal with the firm and concentrates his practice in the area of FDA regulation of medical devices. He has spoken domestically and internationally and written extensively on device and other FDA-related topics, including: FDA regulation of in vitro diagnostics, blood bank software and human cell and tissue products; FDA inspectional and enforcement authority; FDA clinical trial requirements; FDA regulatory obligations of hospitals; and the impact of FDA law on business transactions and agreements. Over the years, Mr. O'Flaherty's device work has included assistance to the Advanced Medical Technology Association (AdvaMed), the nation's largest trade association for the medical device industry, including assistance on device tracking, medical software, and device reclassification matters. His practice also includes legal matters relating to other FDA-regulated products.

Mr. O'Flaherty was born in Chicago, Illinois and received his B.A. with honors in 1987 from University of Notre Dame and his J.D. from Loyola University of Chicago School of Law in 1990. He was admitted to the Illinois Bar in 1990 and the District of Columbia Bar in 1991. Mr. O'Flaherty is currently a member of the District of Columbia Bar and the Illinois and American Bar Associations. He is also a member of the American Health Lawyers Association.

Areas of Practice:

Medical Device Law

Food, Drug, and Cosmetics Law

Bar Admissions:

Illinois, 1990

District of Columbia, 1991

Education:

Loyola University Chicago School of Law, Chicago, Illinois, 1990
Juris Doctor

University of Notre Dame, Notre Dame, Indiana, 1987
Bachelor of Arts
Honors: Cum Laude

Published Works:

"The Increasing Impact of FDA Regulation on Hospitals and Related Institutions," Health Lawyer News, Volume 7, Number 12 (December 2003)

"The Legalese of Outsourcing," Medical Product Outsourcing (October 2003)

"The Impact of FDA Medical Device Regulation on Hospitals," Health Law Digest, Volume 29, Number 1: 3-13 (January 2001)

"Optimizing Use of FDA Regulatory Counsel," Regulating Affairs Focus, Volume 4, Issue 3:37-38 (March 1999)

"Food and Drug Administration Regulation of Blood Bank Software: The New Regulatory Landscape for Blood Establishments and Their Vendors," Transfusion, Volume 38: 86-89, January 1998

"Changing Regulatory Climate for Blood Establishments and Their Vendors," IVD Technology, Volume 3, Number 7: 22-29, November/December 1997

"The Legal Framework for the Regulation of Bulk Pharmaceutical Chemicals," Chapter 3 of Validation of Bulk Pharmaceutical Chemicals. Eds. Berry and Harpaz, 1997

"Comments on FDA Guidelines for In Vitro Diagnostic Products," Regulatory Affairs, Volume 6: 79-86 (Fall 1994)

Presentations:

"FDA Clinical Trial Requirements for Medical Devices," Medical Device Clinical Research and Reimbursement Conference, Phoenix, Arizona (January 2010)

"FDA Medical Device Regulatory Issues Affecting Hospitals," The American Health Lawyers Association's (AHLA) Annual Meeting, Orlando, Florida (June 2001)

"Medical Device Enforcement," The Food and Drug Law Institute's (FDLI) Introduction to Medical Device Law and Regulation, Atlanta (October 1998), Washington, D.C. (March 1998)

Professional Associations and Memberships:

Illinois State Bar Association

District of Columbia Bar Association