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Neil F. O'Flaherty
Neil F. O'FlahertyNeil F. O'Flaherty
Principal Attorney
Washington, District of Columbia,
phone (202) 789-1212
fax (202) 234-3550
email noflaherty@ofwlaw.com

Neil is a Principal Attorney at OFW Law 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 mobile medical apps, other medical software products and in vitro diagnostics; FDA inspectional and enforcement authority; FDA device clinical trial requirements; FDA device regulatory obligations of hospitals; and the impact of FDA device law on business transactions and agreements.  Over the years, Neil'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 FDA regulation of human cellular and tissue-based products (HCT/Ps).

Neil has successfully 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 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 transaction; assisted clients in the negotiation and drafting of FDA regulatory provisions for various business contracts; and assisted clients in the review and drafting of FDA-related sections of reports and documents filed with the Securities and Exchange Commission.

Neil has spent his entire legal career at OFW Law, starting at the firm as an Associate Attorney in 1990.

Neil 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 Illinois Bars. He is also a member of the American Health Lawyers Association and the American Bar Association.

Areas of Practice:
  • Medical Device Law
  • Food and Drug Law
Bar Admission:
  • Illinois, 1990
  • District of Columbia, 1991
Education:
  • Juris Doctor, Loyola University Chicago School of Law, Chicago, Illinois, 1990
  • Bachelor of Arts, University of Notre Dame, Notre Dame, Indiana, 1987
Honors:
  • LMG Life Sciences, Life Sciences Star, FDA Medical Devices (2012-2013)
Professional Associations and Memberships:
  • Illinois State Bar
  • District of Columbia Bar
  • American Bar Association
  • American Health Lawyers Association
Publications:
  • “U.S. Food and Drug Administration Requirements for Importing Medical Devices into the United States.”  China Medical Device Information, Vol. 12, No 1: 38-40 (2006)
  • “How FDA Hopes to Decrease Medical Errors with the Help of Bar Code Technology.”  Health Lawyers News, Vol. 9, Number 12: 4-10 (December 2005)
  • “FDA Considerations Related to Maintaining Clinical Trial Records in Electronic Form,” Health Lawyers News, Vol. 8, Number 12 (December 2004)
  • “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 FDA Affinity Group and FDA Listserve – Important New Resources for AHLA      Members,” Teaching Hospitals & Academic Medical Centers, Vol. 1, Issue 2 (Fall 2003)
  • “U.S. FDA Regulation of Human Cell and Tissue Products,” Eucomed “Medical   Technology Focus” Newsletter (2002)
  • “FDA’s New Regulatory Scheme for Human Cell and Tissue Products,” Journal of Health Law, Volume 35, Number 4: 493-508 (Fall 2002)
  • “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)
  • “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)
Presentations:
  • “Recall Guidance for Drugs, Biologics and Medical Devices – What You Need to Know,” American Conference Institute, FDA Boot Camp, Chicago, Illinois (September 2006) and New York, New York (March 2006)
  • “FDA’s Regulatory Scheme for Human Cells, Tissues and Cellular and Tissue-Based Products.”  Life Science Alley Workshop, St. Louis Park, Minnesota (July 2006)
  • “Recalls of Drugs and Medical Devices: What’s Required, What’s Expected and Practical Pointers,” American Health Lawyers Association, Life Sciences Law Institute, Baltimore, Maryland (May 2006)
  • “Medical Device Advertising: Lessons Learned from Untitled Letters,” FOI Services Teleconference, Washington, District of Columbia (February 2006)
  • “Medical Device Reporting – Requirements, Pitfalls and Enforcement Issues,” American Health Lawyers Association, Teaching Hospitals and Academic Medical Centers Practice Group, FDA Affinity Group Teleconference, Washington, District of Columbia (July 2005)
  • “FDA Requirements for Maintaining Clinical Trial Records in Electronic Form,” Association of American Medical Colleges, Compliance Officers’ Professional Development Conference, Washington, District of Columbia (May 2005)
  • “Device Advertising and Promotion: A Discussion by Industry Experts,” FOI Services Teleconference, Washington, District of Columbia (April 2005).
  • “Relation Between Standards and FDA Guidance: GGP – A Legal Perspective,” Advanced Medical Technology Association, Use of Standards in Submissions, Alexandria, Virginia (February 2005)
  • “FDA and the Products it Regulates,” American Health Lawyers Association, Fundamentals of Health Law, Chicago, Illinois (November 2003)
  • “Legal and Regulatory Requirements for Medical Packaging,” Innovative Technology Conferences, HealthpakSM 2003, Scottsdale, Arizona (March 2003)
  • “FDA’s New Regulatory Scheme for Human Cell and Tissue Products,” American Health Lawyers Association, Teleconference, Washington, District of Columbia (October 2002)
  • “Current FDA and Biotechnology Issues,” American Health Lawyers Association, Annual Meeting, San Francisco, California (July 2002)
  • “Reports of Corrections and Removals Under 21 C.F.R. Part 806,” Advanced Medical Technology Association, Complaints, MDRs, Reports of Removals & Corrections and Recalls, Arlington, Virginia (April 2002)
  • “FDA-Regulated Medical Device Clinical Trials,” American Health Lawyers Association, Legal Issues Affecting Academic Medical Centers and Other Teaching Institutions, Washington, District of Columbia (January 2002)
  • “FDA Medical Device Regulatory Issues Affecting Hospitals,” American Health Lawyers Association, Annual Meeting, Orlando, Florida (June 2001)
  • “Medical Device Enforcement,” Food and Drug Law Institute, Introduction to Medical Device Law and Regulation, Atlanta, Georgia (October 1998) and Washington, District of Columbia (March 1998)
  • “Preparing For The Inspection: Industry’s Perspective,” Regulatory Affairs Professionals Society, FDA Inspection and Enforcement Issues, Bethesda, Maryland (May 1998)
  • “Companies as Sponsors of Medical Device Clinical Studies -- Limitation of Company Liability,” Medical Alley Clinical Studies Committee Meeting, Minneapolis, Minnesota (February 1996)
  • “Overview of Device Regulation,” Food and Drug Law Institute,1995 Summer Internship Program, Arlington, Virginia (June 1995)
  • “Software Validation,” Regulatory Affairs Professionals Society, FDA Inspection and Enforcement Issues: How To Plan, Prepare, And Respond, Washington, District of Columbia (March 1995)
  • “The U.S. Requirements for Postmarket Surveillance of Certain Medical Devices,” EuroAsconet’s First European Conference on Registration Systems [PMS] For Medical Implants, Amsterdam, The Netherlands (June 1994)
  • “Status Of FDA Compliance Policies And Guidelines On IVDs – Industry’s Viewpoint and a Legal Perspective,” Regulatory Affairs Professionals Society, In Vitro Diagnostics Update, Waltham, Massachusetts (May 1994)
  • “Current FDA Regulatory Environment and Legal and Regulatory Considerations That Support An Automated Regulatory Information System,” Regulatory Affairs Professionals Society, Regulatory Information Management Workshop, Bethesda, Maryland (November 1993)
  • “Industry Response To User Reporting,” FDA Medical Device User Facility Reporting Conference, Cambridge, Massachusetts (March 1993). 
Other Activities:
  • Vice Chair, Education, Teaching Hospitals and Academic Medical Centers Practice Group, American Health Lawyers Association (July 2008 to 2010)
  • Vice Chair, Publications, Teaching Hospitals and Academic Medical Centers Practice Group, American Health Lawyers Association (July 2006 to July 2008)
  • Co-Chair, FDA Affinity Group, Teaching Hospitals and Academic Medical Centers Practice Group, American Health Lawyers Association (2003 to 2010)
  • Co-Moderator, FDA Listserve, American Health Lawyers Association (2002 to 2010)
  • Member, H. Thomas Austern Memorial Writing Awards Competition Committee, Food and Drug Law Institute (1999 through 2002)
  • Instructor, Health Industry Manufacturers Association, Basic Medical Device Regulation Seminar, Salt Lake City, Utah (September 1994)
  • Moderator, Device Session on Postmarket Surveillance, Regulatory Affairs Professionals Society, 15th Annual Meeting, Washington, District of Columbia (September 1991).
Pro Bono Work:
  • Volunteer Law Clerk, Legal Assistance Foundation of Chicago (1987)