Medical Devices and Apps Regulatory Challenges

Nik Tehrani, Jahan Ghofraniha


Mobile Medical Applications (MMA), or mHealth apps, are software comprised of complex data analytics and mobile technologies for healthcare professionals that run on a smartphone and/or another mobile communication device. This software converts the mobile platform into a medical device to perform specific healthcare functions. Prior to release to the public, they must have Health Authority (HA) approval. The U.S. Food and Drug Administrations (FDA) regulations criteria are detailed and clear as to how MMAs can qualify as a medical device. The FDA regulates medical devices through the FD & C Act which defines regulatory requirements applying to medical devices. They must meet the definition outlined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and must be used as an accessory to a regulated medical device or on a mobile platform as a regulated medical device. MMAs as medical devices are determined by the intended use of the mobile app. The FDA determines the intended use (such as to cure, prevent, treat, or alleviate a disease) by evaluating manufacturer labeling claims, advertisements, and/or oral and written statements.

Key Words: Regulatory, FDA, Medical Devices, Mobile Medical Applications

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