Smartphones and tablets are revolutionizing healthcare delivery. FDA is catching on to this fact and released draft guidance that would allow it to regulate smartphone and tablet apps related to health and medical needs.
Sounds reasonable - but where do you draw the line? The folks at Brandwood Biomedical give this example:
[A]n app which controls the phones LED flash to turn it into a light source and is labelled as to be used for assisting with a patient examination would be subject to regulation as an ophthalmoscope – which means it would require a 510(k) submission.Really? Does that mean that all of the flashlight apps would be subject to FDA oversight? That would quickly put a damper on the market for smartphone apps.
To help clarify this issue, FDA sets out four categories of mobile apps with separate regulatory approaches (from Brandwood Biomedical):
- Apps which display, store or transmit patient-specific medical device data in original format. These will be regulated as Medical Device Data Systems MDDS – which are Class I under regulation 21 CFR 880.6310
- Apps which control the intended use, function, modes, or energy source of a connected medical device. These apps are considered accessories to the primary connected device and subject to the same regulations as that device. So if the app is accessory to a Class II device – a 510(k) will be required, if it's an accessory to a Class III device subject to PMA, then so is the app.
- Apps which turn the mobile platform into a regulated medical device – Apps that "use attachments, display screens, sensors or other such similar components to transform a mobile platform into a regulated medical device" must meet the regulations for that device type. E.g. the electronic stethoscope apps which use the phones microphone is subject to 21 CFR 870.1875(b) (Electronic Stethoscope).
- Creating alarms, recommendations or creating new information (data) by analyzing or interpreting medical device data – Apps which contain algorithms to analyze or interpret data gathered from another device are considered accessory to that device and therefore again subject to the same regulations which apply to the device which gathers the primary data. Examples include apps which analyze blood glucose readings from glucose meters (Glucose Test Systems under 21 CFR 862.1345) or apps which analyze and display ECG data (Cardiac Monitors under 21 CFR 870.2300).
[Hat tip to @cwsampson]
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