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FDA Releases Guidance Clarifying Regulatory Oversight of Mobile Medical Applications and Software Devices

Recently, the FDA issued a final 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, such as “apps," or on general-purpose computing platforms. According to the document, the FDA will provide regulatory oversight only to those software functions that are medical devices and whose functionality could pose a risk to a patient's safety, if the device were not to function as intended. Specifically, if a software function is intended for use in performing a medical device function (i.e., for diagnosis of disease or other conditions or the cure, mitigation, treatment, or prevention of disease), it is a medical device, regardless of the platform on which it is run and, therefore, will be regulated by the FDA. For all other software applications and apps, the FDA will rely on the Office of the National Coordinator for Health Information Technology (ONC) and its certification program to determine safety.

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