Arlington, Va., February 18, 2015 – The following statement is attributed to Julie Kearney, vice president, regulatory affairs, Consumer Electronics Association (CEA)®, regarding the Food and Drug Administration’s (FDA) release of its final guidance document on medical device data systems (MDDS) and update of its Mobile Medical Apps (MMA):
“The FDA has made an important step forward with its final guidance document on MDDS, confirming the administration’s intent not to enforce regulations for technologies that receive, transmit, store or display data from medical devices. Along with the FDA, CEA hopes this policy will inspire companies to develop new technologies to better use and display this data.
“Consumer tech is having a pronounced impact on the way people manage their health. We strongly support any measure that aims to spur innovation by bringing more mobile apps and products into the healthcare space, while empowering consumers to adopt more methods of personalized health care.”
Last year, CEA joined others in sponsoring an ongoing health and technology educational program series, the “Mobile Medical Apps (MMA) Roadshow.” The program demystifies FDA requirements for new app developers and identifies best practices among those already producing regulated apps.
About CEA:
The Consumer Electronics Association (CEA) is the technology trade association representing the $223 billion U.S. consumer electronics industry. More than 2,000 companies enjoy the benefits of CEA membership, including legislative and regulatory 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 CE.org, DeclareInnovation.com and through social media: