Neil O’Flaherty has been a Partner in Baker McKenzie’s Washington, DC office in the Intellectual Property Practice Group since 2015. Neil also is a member of the Firm’s North America and Global Healthcare Industry Groups. Neil concentrates his practice in the area of U.S. Food and Drug Administration (FDA) regulation of medical devices. Neil has over 27 years of experience in this area.
Neil regularly counsels the FDA-regulated device industry on premarket and post-market issues and strategies. Over the years, Neil’s device work has included assistance to and collaboration with various medical device industry and healthcare groups.
He provides guidance on a myriad of device regulatory issues, such as digital health (including health apps and medical software) as well as device labeling, promotion and advertising issues, among others.
He has spoken domestically and internationally and written extensively on medical device and other FDA-related topics, including: FDA regulation of mobile medical apps and other medical software products, in vitro diagnostics, FDA inspectional and enforcement authority, medical device promotion, FDA device clinical trial requirements, FDA device regulatory obligations of hospitals; and the impact of FDA device law on business transactions and agreements, among other topics.
Neil received his B.A. from the University of Notre Dame in 1987 and his J.D. from Loyola University of Chicago School of Law in 1990.