We use cookies to deliver our online services. Details of the cookies we use and instructions on how to disable them are set out in our Cookies Policy. By using this website you agree to our use of cookies. To close this message click close.

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On 19 July 2011, the Food and Drug Administration (FDA or the Agency) issued a draft guidance document clarifying FDA's view on the regulatory status of mobile medical applications for handheld devices.The draft guidance, titled Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications, outlines a targeted group of mobile applications over which FDA intends to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 The Agency is seeking comments on the draft guidance by 19 October 2011.

Read "Guidance addressing regulation of smartphone and tablet computer apps"

The team

Loading data