Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications; Availability

Samenvatting

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Mobile Medical Applications." FDA is issuing this draft guidance to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (mobile applications or "mobile apps"). At this time, FDA intends to apply its regulatory requirements solely to a subset of mobile apps that the Agency is calling mobile medical applications (mobile medical apps). This draft guidance is not final nor is it in effect at this time.