FDA finalizes Mobile Medical Apps guidance
On 23 September 2013 the FDA released the long-awaited Mobile Medical Applications final guidance.1 Coming more than two years after its initial draft, the final guidance provides further clarity and...
View ArticleFDA Proposes Enforcement Discretion for Medical Device Data Systems, Medical...
In a 20 June 2014 draft guidance, the Food and Drug Administration (FDA or Agency) proposed that, once the guidance is finalized, the Agency would refrain from enforcement of all regulatory...
View ArticleMobile medical apps are a form of medical device — and are regulated as such
As they grow in popularity and functionality, mobile devices increasingly connect people virtually with the places and institutions they would otherwise visit in person. These include malls, banks, and...
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