Nationwide 'roadshow' to educate mHealth app developers about FDA regulations
The Consumer Electronics Association announced its sponsorship of an educational program series, being held at universities across the U.S. aiming to demystify the FDA requirements for app developers and identify best practices among those already producing regulated apps.
Called the "Mobile Medical Apps (MMA) Roadshow: Managing App Development under FDA Regulation," CEA has joined a consortium of universities, industry trade associations and professional societies, including the American Telemedicine Association, Continua Health Alliance, CTIA, GSMA, mHealth Regulatory Coalition, mHIMSS and the Wireless-Life Sciences Alliance.
"Consortium members collectively have hundreds of thousands of members interested in mobile health, representing the vast majority of technology developers in this mobile space and hope to spur economic development in an area where the U.S. has a clear advantage globally," states the announcement.
The MMA Roadshow's first event took place today at the University of Illinois at Chicago. Other workshops, scheduled over the next few months, will be hosted at Johns Hopkins University, University of California-San Diego, Stanford University, University of Texas at Austin and the Massachusetts Institute of Technology.
"FDA recently published its final guidance on mobile medical apps, and while helpful, the guidance leads to more questions. This workshop will focus on answering those questions for app developers in or close to FDA regulated territory," states the MMA Roadshow landing page on the mHealth Regulatory Coalition website. "We will dive deeply into the regulatory issues associated with bringing new mobile apps into the healthcare space."
In September 2013, the FDA issued its final guidance on mobile medical apps. The regulatory agency's document outlined its "tailored approach" and intention to focus on a "small subset" of the app market--those apps that present the greatest risk to patients.
Among the questions that will be addressed in the MMA Roadshow workshops: "how to develop mobile apps that come as close to the FDA line as possible, but don't cross over into regulated territory"; "for those apps that FDA does regulate, how to figure out the appropriate classification in a system that frankly hasn't been updated in a long time"; and, "if your app requires premarket clearance, what predicates are available and more importantly what strategies are there for showing substantial equivalence."
During the four-hour workshops, which charge a $100 fee, attendees "will hear directly from the experts, including regulatory attorneys, regulatory affairs specialists, quality system experts, European law attorneys, experienced mHealth executives and of course, the FDA," according to the organizers.
"It's really all about innovation and regulation, and showing that they can be compatible," Bradley Merrill Thompson, the mHealth Regulatory Coalition's general counsel and the chairman of the steering committee for the MMA Roadshow program, told FierceMobileHealthcare. "We need innovation. Patients need innovation. Our economy needs innovation. But, we also need product safety and we need discipline. And, these are not mutually exclusive. What's so exciting is that there are so many people, many of them from the IT industry with no healthcare background, now innovating in healthcare. So, we want to reach out to those people to help them."
To learn more:
- read the announcement