CABA Information Series

(IS-2012-97) Mobile Medical Applications – Draft Guidance

This draft guidance when finalized will represent the U.S. Food and Drug Administration’s (FDA’s) current thinking on this topic. Its purpose is to inform manufacturers, distributors, and other entities about how the FDA intends to classify and regulate select software applications intended for use on mobile platforms (mobile applications or “mobile apps”), depending on risk.






















(Adobe PDF File)