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Food and Drug Administration, Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff (Feb. 9, 2015) (supersedes "Mobile Medical Applications: Guidance for Food and Drug Administration Staff" (Sept. 25, 2013) (full-text).
The FDA issued this guidance document 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"). Given the rapid expansion and broad applicability of mobile apps, the FDA issued this guidance document to clarify the subset of mobile apps to which the FDA intends to apply its authority.