Neil O’Flaherty

Neil O’Flaherty is a partner in Baker McKenzie’s Intellectual Property Practice Group in Washington, DC. He has over 25 years of experience involving FDA regulation of medical devices.

Mr. O’Flaherty has spoken and written extensively on medical device and other FDA-related topics, including the regulation of mobile medical apps, other medical software products and in vitro diagnostics; inspectional and enforcement authority; clinical trial requirements for devices; device regulatory obligations of hospitals; and the impact of FDA device law on business transactions and agreements.

Mr. O’Flaherty’s practice focuses on FDA regulation of medical devices. His practice also includes legal matters relating to FDA regulation of human cellular and tissue-based products (HCT/Ps).

Over the years, Mr. O’Flaherty has provided assistance to and collaborated with various medical device industry and health care groups, including providing guidance on device tracking, medical software, and device reclassification matters.

Education:

• Loyola University Chicago School of Law (J.D.) (1990)
• University of Notre Dame (B.A.) (1987)

Admissions:

• U.S. Supreme Court~United States (2007)
• District of Columbia~United States (1991)
• Illinois~United States (1990)

Professional Associations and Memberships:

• Illinois State Bar Association
• District of Columbia Bar
• American Bar Association
• United States Supreme Court Bar Association

Representative Legal Matters:

• Prepared 510(k) submissions for clients and obtained 510(k) marketing clearance.
• Conducted FDA regulatory reviews of product labeling and promotional materials.
• Established FDA-compliant complaint handling and medical device reporting systems for clients.
• Resolved clients’ warning letters and Form FDA-483 inspectional observations with the FDA.
• Conducted FDA compliance audits and internal investigations on behalf of clients.