Medical and health applications for iPhones, Blackberry devices, Android phones and other mobile gadgets already number in the thousands. The problem is that only one app, AirStrip OB, actually earned FDA’s explicit blessings to be marketed as a medical device. So the big question is whether the FDA is going to “put its foot down” and require that it provide clearance before new apps go to market. MobiHealthNews has been following this dilemma and provides some thoughts on the direction that regulation of this industry may take.
“At a high-level, we look for two things: (1) a device with (2) a medical intended use. The first prong of the test — that there must be an actual product — means FDA doesn’t regulate, for example, medical procedures. The thing in question must be a thing, and not information or something else intangible. Software can be a medical device if it’s written on computer media, as opposed to printed on paper. The media with the code written on it is enough of a ‘thing’ for FDA to regulate,” Thomspon [Bradley Merrill Thompson, Partner at Epstein Becker & Green] writes. “In the area of mobile health technology, it’s important to understand that an accessory or a component of a medical device is itself a regulated medical device. Further, the difference between an accessory and a component is who buys it. End-users buy accessories, while manufacturers buy components. Thus the exact same piece of equipment could be either an accessory or a component depending on the target purchaser.”