2012 - Live web seminar on FDA Regulation of Mobile Medical Apps By Compliance2go

Why should you Attend:

The number of mobile applications or “apps”, including mobile medical apps, is ever increasing and an undeniable mainstay of medicine moving forward. Anyone planning to enter the mobile medical apps field who plans to market their apps in the U.S. must understand FDA’s plans for regulating mobile medical apps moving forward. Moreover, as FDA’s plans are not yet completely finalized, it is also an opportunity to understand what FDA is planning to do and attempt to impact the process.

Webinar Includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

60 Minutes Live Presentation

Description of the Topic:

On July 21, 2011, FDA issued its draft guidance for the regulation of mobile medical apps. The seminar will summarize FDA’s current plans for regulating mobile medical applications, as described in the draft guidance. It will also explore the practical implications of FDA’s regulatory plans for mobile medical apps manufacturers and marketers, including those firms which provide the mobile platforms on which the “apps” are used. It will also discuss and update attendees on recent Congressional action on mobile medical apps and how the activity affects FDA’s plans.

Who will benefit:

Representatives of manufacturers and marketers of mobile medical applications and mobile platforms as well as other medical devices, including in-house counsel, outside FDA counsel, regulatory affairs personnel, and regulatory consultants

About Speaker

Mr. O'Flaherty is a principal with the firm 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 in vitro diagnostics, blood bank software and human cell and tissue products; FDA inspectional and enforcement authority; FDA clinical trial requirements; FDA regulatory obligations of hospitals; and the impact of FDA law on business transactions and agreements. Over the years, Mr. O'Flaherty'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 other FDA-regulated products.
Mr. O'Flaherty 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 the Illinois and American Bar Associations. He is also a member of the American Health Lawyers Association.

Mr. Terman is a principal at OFW Law. He was born in Washington, DC, and received his B.S. in economics in 1973 from the University of Maryland where he was Phi Kappa Phi and his J.D. in 1976, also from the University of Maryland. Mr. Terman was admitted to the Maryland Bar in 1976 and the District of Columbia Bar in 1979. He is currently a member of the District of Columbia Bar