FDA Will Regulate Some Apps As Medical Devices

chicksdaddy writes "In an important move, the U.S. Food & Drug Administration (FDA) has released final guidance to mobile application developers that are creating medical applications to run on mobile devices. Some applications, it said, will be treated with the same scrutiny as traditional medical devices. The agency said on Monday that, while it doesn't see the need to vet 'the majority of mobile apps,' because they pose 'minimal risk to consumers,' it will exercise oversight of mobile medical applications that are accessories to regulated medical devices, or that transform a mobile device into a regulated medical device. In those cases, the FDA said that mobile applications will be assessed 'using the same regulatory standards and risk-based approach that the agency applies to other medical device.' The line between a mere 'app' and a 'medical device' is fuzzy. The FDA said it will look to the 'intended use of a mobile app' when determining whether it meets the definition of a medical 'device.' The Agency may study the labeling or advertising claims used to market it, or statements by the device maker and its representatives. In general, 'when the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment or prevention of disease, or it is intended to affect the structure of any function of the body of man, the mobile app is a device.'"

Re:Woohoo!

[cayenne8]

I'm guessing it is also a nice move to allow more tax revenue to be gathered due to be being categorized as a medical device....another nice little by product of obamacare (the increased taxation of medical devices).

Re:Woohoo!

[Alternate Interior]

Speaking as a Diabetic- yes I do.

I wear an infusion pump already. And a continuous monitor. They're plastic screens and buttons I clip to my belt. They have to be easily accessible because there is so much variance day-to-day.

Having everything talk via ANT or BT or something. Having one controller for it all. It'd be wonderful. I think your point is that it's too dangerous to put all that burden on a single piece of commodity hardware. And that's a valid point, in theory. But in reality, if I can replace the pump UI and CGM UI with a phone **that I'm already carrying** I end up with a whole lot fewer widgets to keep track of. Also, by virtue of commoditization, I could replace the software stack infinitely easier than a purpose-built controller, Dangerous? Sure. But understand the position we're in now:

1. Taking too much insulin is deadly.
2. It's easy to take too much insulin.
3. Since 2009, pumps and CGMs have been available in much of the world which automatically stop delivering insulin when your blood sugar is low.
4. The FDA has not allowed this technology in the United States.

I don't care if it's dangerous or voids the warranty or puts the FDA boogey-man on me. If a development like this occurs in the future and the FDA impedes it, I would like the opportunity to get it. Running on an open stack, even a quasi-open stack, is the only viable way for that to happen. And for today, smartphones are the best way to make that happen.

Software is not special just because it's mobile.

[melstav]

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 [fda.gov], 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.