The Food & Drug Administration (FDA) released guidance on mobile health applications on September 25, 2013. The guidance states that the FDA will focus its oversight activities on mobile health applications that are intended to be used as an accessory to a medical device or to transform a mobile platform into a medical device. The guidance emphasizes that the FDA will not target those mobile applications that the FDA does not consider to meet the definition of a medical device, and would not be subject to the guidance. The guidance also states that the FDA will exercise enforcement discretion of mobile health applications that track and log patient health data, meaning that the FDA would not enforce medical device standards on thse products, because they pose a minimal risk to consumers.
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