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The agency’s draft guidance defines a small subset of mobile medical apps that impact or may impact the performance or functionality of currently regulated medical devices.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