Since the day the U.S. Food & Drug Administration (FDA) published its final guidance on mobile medical apps last September, app developers have been trying to determine how the FDA guidance impacts their particular apps and business plans. Now, a consortium of six leading universities, more than a dozen industry trade associations and professional societies – including NVCA, and the FDA are poised to help developers do just that through a series of educational programs called “MMA Roadshow: Managing App Development under FDA Regulation.”
Targeting entrepreneurs and innovators, the MMA Roadshow aims to demystify the FDA requirements, improve understanding of the process for innovating in this regulated space, and identify best practices among those companies already producing regulated apps. It will consist of six events distributed evenly between the East Coast, West Coast and Midwest and Southwest. (A complete schedule can be found here.)
Each four-hour program will include a mix of presentations and panel discussions featuring participants who are either involved in or who have successfully navigated the FDA process for obtaining clearance from the agency to market their app. They will share what they have learned from a regulatory strategy perspective, as well as what they have encountered from a business perspective. Officials from the FDA will participate actively in the program, both helping to explain its requirements and fielding difficult questions.
The consortium has designed the MMA Roadshow to accomplish the larger goal of advancing patient care by encouraging the development of apps at the higher benefit/higher risk end of the spectrum – where the opportunities to improve patient outcomes and spur economic development are the greatest.
For more information about the MMA Roadshow Consortium, or to register, you can go to www.mHealthregulatorycoalition.com/events. As a member/sponsor, NVCA can offer its members a 50 percent discount on registration. To obtain the discount code, please contact Lisa Blackburn at firstname.lastname@example.org.