In a draft proposal, the agency defines a small subset of mobile medical apps that affect or may affect the performance or functionality of currently regulated medical devices. This subset includes mobile medical apps that:
- Are used as an accessory to medical devices 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
- 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 electrocardiogram machine to detect abnormal heart rhythms or determine whether a patient is experiencing a myocardial infarction).
The draft guidance excludes the following from regulation:
- Mobile apps that are electronic "copies" of medical textbooks, teaching aids or reference materials, or are solely used to provide clinicians with training or reinforce training previously received.
- Mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness. Such decisions, suggestions, or recommendations are not intended for curing, treating, seeking treatment for mitigating, or diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition.
- Mobile apps that only automate general office operations with functionalities that include billing, inventory, appointments, or insurance transactions.
- Mobile apps that are generic aids that assist users but are not commercially marketed for a specific medical indication.
- Mobile apps that perform the functionality of an electronic health record system or personal health record system.
The agency is seeking input from the public on its draft guidance. Comments can be submitted for 90 days online or by writing to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. The FDA will update the guidance based on feedback received.
