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Guidance addressing regulation of smartphone and tablet computer apps

25 July 2011

Medical Device Alert

On 19 July 2011, the Food and Drug Administration (FDA or the Agency) issued a draft guidance document clarifying FDA's view on the regulatory status of mobile medical applications for handheld devices.The draft guidance, titled Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications, outlines a targeted group of mobile applications over which FDA intends to exercise regulatory oversight. The Agency is seeking comments on the draft guidance by 19 October 2011.

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