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By Bradley Merrill Thompson, Partner, Epstein Becker & Green, P.C.

Last month I outlined the triggers that could cause an ordinary mobile phone to become an FDA-regulated medical mobile phone. This month, in the second of six planned articles, I will outline the FDA requirements that would apply to a mobile phone that crosses that line.

To summarize the July 13 article on “FDA may regulate certain mobile phones, accessories”, a mobile phone could become a regulated medical device if the manufacturer, through its words and deeds, conveys an intention that the phone be used in medical applications. I also pointed out that medical devices come in at least three different flavors: (1) standalone medical devices, (2) accessories and (3) components to such devices.

Premarket clearance or approval

In contrast to components that are simply sold to another manufacturer, standalone medical devices and accessories sold to end users may require some form of premarket clearance or approval. Once you know you have an FDA-regulated device or accessory, here’s how you figure that out, following a five-step process.

Step one. Figure out the most appropriate classification for your product.

There is a bit of both art and science to this. FDA has published about 1700 classification regulations. Each of those regulations has a description or “identification” of the types of devices covered by that regulation. FDA has a searchable database of these regulations accessible through their website.

Some articles of hardware and software are so important that FDA has separately classified them, and you can find them directly through searching. The regulations are organized by clinical application so all of the orthopedic devices, for example, are in one part of the regulations. So you might get lucky and find one that directly describes your product. A quick search of the regulations revealed that the word “computer” appears in 225 regulations, “software” in 431 and “network” in 43. There is, for example, a classification for remote medication management systems in 21 CFR 880.6315.

But if you can’t find one that directly describes your product, perhaps it’s because FDA considers your product to be merely an accessory to a “parent” device. I’ll give you an example. Last month FDA cleared an updated version of the Polytel glucose meter accessory, which is a small module that plugs into the port of a glucose meter, receives data from the meter and transfers it wirelessly to an Internet capable communication device like a cell phone or an APT. In clearing the device, FDA agreed with its classification in 21 CFR 862.1345, which covers all glucose test systems, including the “parent” glucose meters. Keep reading>>