On September 23, 2013, the FDA issued a guidance (“Final Guidance”) explaining how medical device regulations will be applied to medical mobile applications (MMAs). The Final Guidance provides mobile application manufacturers with recommendations on how to comply with the regulatory and statutory requirements governing medical devices. The Guidance indicates that the FDA intends to limit its enforcement authority to only those mobile applications that operate as medical devices and pose a significant risk to patients if they fail to function as intended.
The Final Guidance outlines three categories of mobile applications (mobile apps) generally: (1) mobile apps that are not medical devices as defined under the Federal Food, Drug, and Cosmetic Act and are therefore not subject to FDA regulation; (2) mobile apps that may meet the definition of a medical device but over which the FDA intends to exercise enforcement discretion because these applications pose a low risk to the public; and (3) mobile apps that meet the definition of a medical device and which the FDA will regulate due to the significant potential risk to patient safety.
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