DISCLAIMER: I am, (among other hats) a software developer for a medical device manufacturer in the United States.
Seriously, people. The FDA's stance has *ALWAYS* been that if something has a medical purpose or is an accessory to a medical device, then it *IS* a medical device, even with software. See: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated 2005.
For the purposes of this document, we refer to devices that contain one or more software components, parts, or accessories, or are composed solely of software as “software devices,” including:
- firmware and other means for software-based control of medical devices
- stand-alone software applications
- software intended for installation in general-purpose computers
- dedicated hardware/software medical devices.
- accessories to medical devices when those accessories contain or are composed of software.
This guidance applies to software devices regardless of the means by which the software is delivered to the end user, whether factory-installed, installed by a third-party vendor, or field-installed or -upgraded.
So, yes, apps with a medical purpose are medical devices, just like any other piece of software.
Which means they *ARE* subject to the "Obamacare Tax" -- Which is *NOT* a "sales tax" to be paid by the consumer. It's an "income tax" to be paid by the manufacturer / developer.
This also means that if your app is categorized as a medical device, you (the developer) have to register with the FDA as a device manufacturer, which costs a couple thousand dollars a year, and means that every few years, the FDA sends someone out to review your quality control system, which includes your testing methodologies, what complaints you've received and how you've handled them, how you document your development process, etc.
AND what your software does determines what kind of medical device the FDA calls it. And the kind of medical device determines whether you are required to get the FDA's permission before you distribute it. (even if you distribute it for free) And yes, applying for that permission costs money, whether it's approved or not.
And, by the way: Each country makes its own rules about what makes a medical device and what you're required to do to be able to legally distribute it in that country. And in most countries that includes software.