Back in February we reported that the Food & Drug Administration (FDA) had just begun its conversation with the mobile health industry and that the ways in which it would regulate this emerging industry would come out of that conversation.
It's now November and those working on wireless health are getting antsy. When will the FDA weigh-in?
For the past few months, Bradley Merrill Thompson, Partner at Epstein Becker & Green, has penned contributed articles for MobiHealthNews that outline how the FDA might regulate wireless health under its existing system.
"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 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."
To get a better understanding of the FDA's potential role in regulating wireless health, be sure to read Thompson's article on Mobile Phones and Certain Accessories and also Thompson's Step-by-Step Guide to Wireless Health Regulation.
Just this week the medical technology blog MedGadget wrote that the “U.S. FDA and other regulatory agencies are far behind the times that we live in, so they have no current policies to deal with the proliferation of mobile computing devices and their potential uses in medicine. Hence, none of the iPhone applications and attachments are classified as medical devices, so they are sold for nonmedical uses only.”
Of course, the AirStrip OB iPhone app has already attained FDA clearance, but what about the other iPhone apps intended for use in clinical settings? Many of them would qualify for FDA regulation under Thompson's analysis.
It's become a common refrain from those wireless health device makers and service providers who have already gone through FDA clearance: Soon the FDA will swoop in and regulate medical apps for smartphones.
We are beginning to wonder: Will the regulatory gavel fall in 2010?