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Mobile Apps Regulated by FDA

FDA has published an announcement about regulations regarding medical mobile applications.

The agency’s draft guidance defines a small subset of mobile medical apps that impact or may impact the performance or functionality of currently regulated medical devices. This subset includes mobile medical apps that:

a. are used as an accessory to medical device already regulated by the FDA
(For example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet); or

b. transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices
(For example, an application that turns a smartphone into an ECG machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack).

Fortunately, some specific apps won’t be regulated:

  • “that are electronic “copies” of medical textbooks, teaching aids or reference materials
  • “that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness.
  • “that only automate general office operations with functionalities that includebilling, inventory, appointments, or insurance transactions.
  • “that are generic aids that assist users but are not commercially marketed for a specific medical indication”
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4 Comments Post a comment
  1. Of course apps that are directly related to the FDA should be regulated. It is important that the public has the right information from a credible source. But, there are many apps that will not be regulated that will still provide high quality information. Not everything can be regulated. It will be up to the user which to decide to use.

    July 28, 2011
    • You are right, and it might lead to some discrepancies regarding which app should be regulated and which not.

      August 1, 2011

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