On July 21, 2011 the FDA released a draft Guidance document on Mobile “App’s”. There is a 90 day period to submit comments for consideration. (See details on web link for draft guidance).
The draft guidance document states in section IV: “This guidance explains FDA intentions to apply its regulatory requirements to a subset of mobile apps. This subset, which we are calling mobile medical apps as defined in section III (definitions), includes only those that meet the statutory definition of a device; and either:
- are used as an accessory to a regulated medical device;
- or transform a mobile platform into a regulated medical device.
This guidance does not specifically address wireless safety considerations, classification and submission requirements related to clinical decision support software, or the application of quality systems to software. The FDA intends to address these topics through separate guidance(s).”
Also, the draft guidance details a long list of app’s that don’t fall under this draft guidance document.