There seems to be a mobile app for just about everything now. Among the multitude of apps available are an increasing number of medical apps. In response to this growing trend, the FDA has issued a final guidance document for developers of mobile medical apps. The guidance explains that the FDA plans to limit its scrutiny to apps that transform a mobile device into a regulated medical device or are intended to be used as an accessory to a regulated medical device because these types of apps could be harmful if they don’t function properly.
The final document follows a draft issued in July 2011 that received more than 130 comments. In response to comments seeking more clarity, the FDA included in the final version more examples of what the agency does and does not intend to regulate. According to the guidance document, examples of apps that will be the subject of oversight include apps that calculate the amount of radiation to be given to a cancer patient and apps that control inflation and deflation of a blood pressure cuff. The guidance indicates that these types of apps essentially perform the functions of traditional medical devices, and notes that the FDA will regulate them as it does traditional devices.
According to the guidance document, the agency plans to leave low-risk apps alone, even those that might fall under the definition of a medical device. For example, apps that allow doctors or patients to log blood pressure readings or diet related apps that recommend the number of calories a person should consume may not be scrutinized. The guidance document also clarifies that providers of medical apps, for example, the iTunes app store, will not be treated as medical device manufacturers.