My name is Neil F. O'Flaherty, but people call me Neil F. O'Flaherty. Here is my homepage: . I live in United States and work as an at

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Neil F. O'Flaherty - FDA Regulations Expert

Neil F. O'Flaherty

Food and Drug Administration (FDA) Regulation, Medical Device, Pharma

Mr. O’Flaherty has been a Principal with Olsson Frank Weeda Terman Matz PC since 1997, and was an associate with the firm from 1990 through 1996.  He concentrates his practice in the area of U.S. Food and Drug Administration (FDA) regulation of medical devices as well as human cells, tissues and cellular and tissue based products (HCT/Ps).  Mr. O’Flaherty has counseled numerous clients on legal and policy issues related to medical devices, HCT/Ps and other articles regulated by FDA.  He acts as a liaison with FDA on behalf of clients, and researches and analyzes complex and sophisticated matters for clients.  His areas of expertise include: medical device establishment registration and listing, premarket issues (including Investigational Device Exemptions, premarket approval and premarket notification); Quality System Regulation; medical device reporting; labeling; and other device related regulatory topics. Mr. O’Flaherty’s experience includes: acting as outside counsel for the Advanced Medical Technology Association (AdvaMed), the nation’s largest trade association for the medical device industry, on device tracking, software, medical glove, device reclassification and other issues; conducting internal investigations and regulatory audits; advising on and drafting responses to FDA Warning Letters and Forms FDA-483; preparing and filing trade complaints with FDA; coordinating and drafting premarket applications for filing with FDA; reviewing FDA-related materials and provisions for business contracts and Securities and Exchange Commission filings; and conducting “due diligence” reviews for FDA compliance issues for mergers and acquisitions.

Mr. O’Flaherty has spoken domestically and internationally and written extensively on medical device, HCT/P and other FDA-related topics, including: FDA regulation of  invitro diagnostics; blood bank software, FDA inspection and enforcement authorities; FDA clinical trial requirements; FDA regulatory obligations of hospitals, and the impact of FDA law on business transactions and agreements.

Mr. O’Flaherty received his B.A. with honors in Government and International Relations from the University of Notre Dame in 1987.  He received his J.D. from Loyola University of Chicago School of Law in 1990.

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