Today, the Consumer Electronics Association (CEA)® announced
its sponsorship of an educational program series called the "Mobile
Medical Apps (MMA) Roadshow: Managing App Development under FDA
Regulation," joining a consortium of six leading universities, more
than a dozen industry trade associations and professional societies, and
the U.S. Food & Drug Administration (FDA). The MMA Roadshow events,
taking place at universities across the U.S., aims to demystify the FDA
requirements for new entrant app developers and identify best practices
among those already producing regulated apps.
"There are huge opportunities for healthcare providers to monitor and
diagnose remotely, and for individuals to take a major role in their own
healthcare with fewer trips to the doctor," said Gary Shapiro, president
and CEO, CEA. "Consumers are increasingly using electronics to manage
their health, and we are thrilled to support a program that aims to spur
innovation by bringing more mobile apps into the healthcare space."
Late last year, the FDA published its final guidance on mobile medical
apps, clarifying that the administration regulates the higher-risk
portion of mobile apps, those intended for use in the diagnosis or
treatment of diseases or other conditions. Since then, companies have
been examining the final guidance in an effort to determine how it
impacts their particular apps and busines plans.
"Mobile apps offer incredible opportunities to improve the quality of
patient care, as well as its effectiveness and efficiency, and so far
developers have barely scratched the surface," said Bradley Merrill
Thompson, the chairman of the steering committee for the program. "We
hope to encourage and help more companies enter this space."
With a focus on entrepreneurs and innovators, the MMA Roadshow and its
content are both geographically and economically accessible. The
consortium members, industry trade groups and professional societies all
volunteered to do their part to connect these educational opportunities
with budding entrepreneurs. 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.
The first workshop takes place today, January 16, at the University of
Illinois at Chicago. For more information about the program, dates,
agenda and participating organizations, visit www.mHealthregulatorycoalition.com/.
The Consumer Electronics Association (CEA) is the technology trade
association representing the $208 billion U.S. consumer electronics
industry. More than 2,000 companies enjoy the benefits of CEA
membership, including legislative advocacy, market research, technical
training and education, industry promotion, standards development and
the fostering of business and strategic relationships. CEA also owns and
produces the International CES - The Global Stage for Innovation. All
profits from CES are reinvested into CEA's industry services. Find CEA
online at www.CE.org,
and through social
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