Yes, That's a Device

Thursday, October 07, 2010

According to many reports, FDA has been showing interest in the booming business of mobile phone apps. Some people have jumped to the conclusion that this must mean FDA considers cell phones to be medical devices.

The confusion around this is understandable, as it relates to a question we hear a lot: How can a piece of software or an algorithm be considered a "device" if it's not a physical thing?

A quick check of the official definition in 201(h) of the FD&C Act doesn’t help much. A device, according to regulation, is an "...instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article" that is used for a medical purpose.

So software must be a "contrivance" because all the rest of those categories sound an awful lot like things. That may well be a correct answer, but it's not a very satisfying one. It still seems to cut against our understanding of what a "device" is.

But is our understanding of the word "device" actually correct? Actually, no... at least, not in historic terms.

Modern speakers tend to use "device" as a synonym for "thing" but that's not its full meaning. Historically (even until fairly recently) the word had a broader meaning that included ideas and plans. It was more synonymous with "means" or "product" and less specifically about stuff.

You can see evidence of this history in the phrase "left to his own devices." It's pretty clear that when you leave someone to their own devices, you're not leaving them with machinery. You're leaving them with their desires, plans, their aspirations and know-how.

Lest we be satisfied with a single data point, it's also clear that quotable writers of previous generations had a much different sense of what "device" meant:

"Democracy is a device that insures we shall be governed no better than we deserve." — George Bernard Shaw

"Corporation: An ingenious device for obtaining profit without individual responsibility." — Ambrose Bierce

"A newspaper is a device for making the ignorant more ignorant and the crazy crazier." — H.L. Mencken

Whether you agree with the sentiments or not, each of these guys knew how to write. None of them were the types of people to be confused about the definitions of basic words. Clearly each of them felt that the meaning of "device" was broad enough to encompass the idea of a social institution.

You can see a bit more evidence for this history in the verb "devise". When you determine a course of action, you can be said to devise a plan. If you devise a plan, is the plan you devise considered a device?

Actually... yes. That's exactly what the word means, as far as Merriam-Webster is concerned.

The etymology of device suggests it and devise share a common origin with the word divide. Division is the process of separating things. When you solve a problem, you separate it into smaller units... thus you would devise a solution. The output of your dividing and devising is a device. A physical artifact is one of many possible ways to capture a solution you have devised.

Today, we tend to use "device" in a different way, and language does this. Like genetics, it evolves. What may be an error to one generation is part of the code for another. Give a mutation a couple generations to take hold and it may just come to define the species.

Ultimately, words mean what people think they mean, so there is some inherent futility to arguing about what words used to mean or what they should mean.

Then again, FDA uses this word an awful lot and when they say "device" they don't just mean something with physical substance. The diagnostics industry uses this definition too, if only begrudgingly.

Whatever you think device should mean, one thing is clear: the way FDA uses the word incorporates abstract products like algorithms and software. The dictionary thinks a device is "something devised or contrived" and considers "equipment" only one of many senses in which the word can be applied.

So perhaps the historic definition of the word hasn’t fallen out of use after all. Perhaps it's been right here in front of us all along.

 

Tags: FDA, FDA 101, Industry

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