As Mobile Applications Cross Over Into FDA Regulatory Territory, New Frictions Emerge

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Updated April 9, 2024

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Device Software Functions Including Mobile Medical Applications - FDA.gov

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We want mobile apps, and it's going to be a very tough regulatory balancing act . . .

As Mobile Applications Cross Over Into FDA Regulatory Territory, New Frictions Emerge - RAPS - News - Article View:

"The emerging clash follows FDA’s promulgation of draft guidance in July 2011, when it proposed some basic regulatory principles for mobile medical application developers. Those principles include which apps would—and which apps would not—be regulated under FDA’s authority, FDA’s regulatory approach toward those applications, general categories for mobile medical applications and corresponding levels of anticipated FDA regulation, and regulatory requirements for developers and manufacturers of applications.

“That seemed reasonable enough to the traditional medical-device industry, which is well-versed in the ways of the FDA,” explained Politico. “But the requirements — data on effectiveness, possibly clinical trials — have gobsmacked some software developers who are used to working in the fast-paced, relatively unregulated wilds of the Internet.”"

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