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FDA mulls regulations for smart phone health apps

by Brendon Nafziger, DOTmed News Associate Editor | September 14, 2010
The U.S. Food and Drug Administration confirmed with DOTmed News that it's considering regulating medical smart phone apps. The agency said it is already working on policies that it will publish later for public comment.

"Draft guidance is being developed that will help clarify an appropriate policy and role for FDA regarding the regulation of mobile applications, including those on smart phones," Dick Thompson, an FDA spokesman, told DOTmed News by e-mail today.

"Some mobile applications are very similar to traditional software applications that the FDA has already classified or regulated, but we believe that further clarifications on mobile applications would be helpful. The FDA will publish its guidance as a draft to allow for public input before issuing a final document," he said.
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In May, DOTmed News looked at the impact FDA regulations could have on the burgeoning medical smart phone app business.