Does an App Count as a Medical Device?

Does an App Count as a Medical Device?

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    In today’s video, we return to the topic of medical devices to address a more specific question: are apps medical devices? If you’ve seen our previous video on medical devices, you’ll recall the definition that medical devices had to be an instrument, apparatus, implement, etc.  But a big question from our health and wellness industry clients working in the digital space is how an app fits in to all of this.

    I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We’ve advised over a thousand healthcare industry clients on healthcare and FDA legal issues. Today, I’m going to explain just how apps fit into the medical device picture.

    After mobile apps arrived on the scene, the FDA issued a Guidance document in 2013 to clarify what kinds of mobile apps would be considered medical devices.  The Guidance divided apps into three categories: “mobile medical apps,” which the FDA would regulate as medical devices; apps that the FDA would not regulate as medical devices; and apps for which the FDA would exercise enforcement discretion.

    The FDA stated that in determining whether the app met the definition of a medical device, they would consider the intended use of the app as shown by labeling claims, advertising materials, or oral or written statements by manufacturers and their representatives.

    The FDA also has a classification called Medical Device Data System (“MDDS”) for a hardware and software products that aren’t classed as regular medical devices. An MDDS can be any product that transfers, stores, converts formats, and displays medical device data.  An MDDS does not modify the data or modify the display of the data, and it does not by itself control the functions or parameters of any other medical device.  MDDSs are not intended to be used for active patient monitoring.

    Examples of MDDSs include:

    • software that stores patient data such as blood pressure readings for review at a later time;
    • software that converts digital data generated by a pulse oximeter into a format that can be printed; and
    • software that displays a previously stored electrocardiogram for a particular patient.

    Thanks for watching.  Here’s to the success of your healthcare venture, we look forward to speaking with you soon.


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