Friday, April 20, 2012

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

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"The emerging clash follows FDA’s promulgation of draft guidance in July 2011, when it proposed some basic regulatory principles for mobile medical application developers.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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2 comments:

GMP Manufacturers said...

Hello, I am very happy to read your blog. This is another fantastic blog post what I have read. There are so many tools available that it becomes difficult to know which will work. And how best to use them.

Conry Lavis said...

Nice article.This is so much more than i needed!!! but will all come in use thanks!!
Mobile Application Development

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