About Neil O’Flaherty

Neil O’Flaherty is a seasoned veteran with over 28 years of legal experience representing medical device and other clients regulated by the U.S. Food and Drug Administration (FDA). From multinational firms to start-ups, companies look to Neil for key guidance and assistance because of his strong substantive knowledge of complex FDA requirements and policies, combined with his ability to provide insightful advice which allows firms to succeed and accomplish their business goals in a highly-regulated industry. Neil also is highly sought after as an accomplished and effective advocate and “problem-solver” for his clients when they face compliance, enforcement and other issues with FDA and other regulators, including governmental investigations and inquiries. Neil also has extensive experience in shepherding clients through recalls and other field actions involving distributed product.

Besides product manufacturers, Neil routinely represents distributors, trade associations, hospitals, and venture capital and private equity groups. He has even provided advice and counsel to a foreign governmental entity.

Neil prides himself on being able to astutely advise and assist clients, with Class I, II or III medical devices, at any stage in their product’s premarket and commercial lifecycle. This work includes counseling on cutting-edge issues such as FDA’s evolving regulatory oversight and framework for digital health products (both general wellness and actively-regulated device products) as well as the new emerging legislative initiatives which will redefine FDA regulation of clinical in vitro diagnostic tests, including laboratory-developed tests.

Examples of the type of work that Neil regularly carries out for clients include:

• Developing FDA-compliant commercialization plans and strategies for their medical devices;

• Preparing 510(k) and other marketing submissions for clients;

• Conducting FDA and FTC regulatory reviews of product labeling and promotional materials;

• Establishing FDA-compliant complaint handling and medical device reporting systems for clients;

• Resolving clients’ Warning Letters, Form FDA-483 inspectional observations, and other compliance issues with FDA;

• Conducting FDA compliance audits and internal investigations on behalf of clients;

• Conducting FDA regulatory due diligence assessments as part of mergers, acquisitions and other business transactions;

• Assisting clients in the negotiation and drafting of FDA regulatory provisions for various business contracts; and

• Assisting clients in the review and drafting of FDA-related sections of reports and documents filed with the U.S. Securities and Exchange Commission and similar regulators.

Beyond the FDA medical device regulatory space, Neil frequently assists clients with matters concerning FDA regulation of combination products and human cells, tissues and cellular and tissue-based products as well as with FDA requirements applicable to medical and non-medical radiation-emitting electronic products. His work in assisting clients with promotional activities regularly broadens his legal assistance to include feedback on compliance with Federal Trade Commission (FTC) requirements.

Known for creativity and thought leadership, Neil is a regular speaker and author on FDA medical device and other FDA regulatory matters. Besides numerous domestic speeches and appearances, Neil has been asked to present on important FDA issues and developments in Canada, Japan, the United Kingdom, France, Germany, Switzerland and the United Arab Emirates. Over the years, Neil has spoken at conferences and seminars sponsored by the Food and Drug Law Institute, the American Health Lawyers Association, the Regulatory Affairs Professionals Society, the American Conference Institute, the Health Care Compliance Association and other organizations.

Outside the office, Neil likes to spend time with his wife and daughter, probably watching too much Netflix with them. He also likes to muse about Notre Dame’s next national championship in football and the next World Series championship for the White Sox. He is convinced it is only a matter of time for both…really.