Statement by Bradley Merrill Thompson, General Counsel, mHealth Regulatory Coalition, on the Food and Drug Administration’s Final Guidance for Mobile Medical Application Developers

Statement by Bradley Merrill Thompson, General Counsel, mHealth Regulatory Coalition, on the Food and Drug Administration’s Final Guidance for Mobile Medical Application Developers 

Mr. Thompson is a well-known and respected expert on issues related to FDA regulation of medical technologies.  He is available for comment on the FDA final guidance on mobile medical technologies and other developing FDA issues. 

We applaud the U.S. Food and Drug Administration for issuing guidance that will illuminate a pathway for developers of mobile health applications.  This final guidance brings greater clarity to one of the most vibrant sectors of health care innovation and will serve as a catalyst for more rapid development of apps that are redefining American medicine.

There are two aspects of the FDA’s final guidance that are particularly praiseworthy.  First, the agency has drawn a clear line of separation between mobile applications that pose minimal, if any, risk to consumers and those that are integral to health care diagnosis and delivery by medical professionals.  By essentially deregulating many of the health-related apps that can transform smartphones into wellness devices, the FDA has performed a tremendous service for patients and consumers.

Also, the FDA has recognized the fast-moving nature of the mobile application industry and has created a guiding mechanism that is not static, but that allows adaptability to innovation.  It is significant that the agency is creating a dynamic webpage to see real-time comments and questions about the regulatory approach to mobile applications.  It is encouraging, to say the least, that a federal agency sees the importance of flexibility in working with a technological sector that is in a state of constant evolution.

There are still questions, of course, as to how the FDA will oversee mobile applications that have, in its determinations, the potential for greater risk.  For now, though, this guidance shows a genuine desire on the part of regulators to be advocates for innovation and health care transformation.