Neil O'Flaherty is a partner in Baker McKenzie’s Intellectual Property Practice Group in Washington, DC. He has over 28 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.
Representative Legal Matters
- Assisted clients in developing FDA-compliant commercialization plans and strategies for their medical devices and HCT/Ps.
- Registered clients' establishments and listed their medical devices with FDA.
- 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.
- Conducted FDA regulatory due diligence assessments as part of mergers, acquisitions and other business transactions.
- Assisted clients in the negotiation and drafting of FDA regulatory provisions for various business contracts.
- Assisted clients in the review and drafting of FDA-related sections of reports and documents filed with the Securities and Exchange Commission.
Professional Associations and Memberships
- Illinois State Bar Association
- District of Columbia Bar
- American Bar Association
- American Health Lawyers Association
- United States Supreme Court Bar Association
- U.S. Supreme Court~United States (2007)
- District of Columbia~United States (1991)
- Illinois~United States (1990)
- Loyola University Chicago School of Law (J.D.) (1990)
- University of Notre Dame (B.A.) (1987)