FDA Report Card 2015: Mobile Medical Apps Regulation

Mobile Medical Apps Regulation

FDA has taken an appropriate light touch to the regulation of mobile medical apps. They really should be applauded for encouraging innovation in this space.

—Bradley Merrill Thompson, shareholder, Epstein Becker & Green

Mobile medical apps are no different than any other medical 'device'— the more important question is, 'What is a medical device?' Whether mobile medical apps, IVDs, 3-D printing, biomedical nanotechnology, tissue engineering, etc.., the list of new technologies that challenge the old regulatory paradigm will continue to increase. Perhaps the problem is that we continue to draw lines in the sand between devices, drugs, biologics, foods, cosmetics, etc. Regardless of the product or what its called, maybe we should stop focusing on drawing lines and instead focus on doing what makes sense? Shakespeare said a rose by any other name still smells as sweet. Are mobile medical apps really any different?

—Michael Drues, PhD, president, Vascular Sciences