Medical Apps: FDA Forgets the ‘RH’ Factor, takes a ‘D’

Medical Apps: FDA Forgets the RH Factor, takes a D.

This week, FDA finally gave us much ado about nothing – its official word on regulating medical “apps” for machines like smartphones.

What? You didn’t realize iPhone apps could be medical devices under FDA’s jurisdiction? Today’s apps market offers very, very medical apps including some where one glitch could kill you. The market is growing bigger and the apps more complex. And FDA’s new, final guidance is: a Safe Harbor big enough for the Queen Mary.

FDA’s new Safe Harbor basically reserves Agency scrutiny for medical apps that work like a traditional medical device (think, ECG monitor) or change the function of an existing device (think, remote reporting of a hospital monitor). In short, it’s not the construction but the function that matters. Your iPhone, to everyone’s relief, is not automatically a medical device that requires proof it won’t blow up your hospital’s machinery.

Sounds more like common sense, not newspaper headlines.

So why is a three-cheers, informal guidance document even newsworthy? Perhaps for what it didn’t say.

You see, FDA’s safety responsibilities aren’t limited to software that sends a doctor the wrong glucose level. FDA’s device center also regulates products that emit radiation. No, not just like x-ray machines but all kinds of radiation. Microwave ovens. Suntan beds. Computer monitors. And yes, cell phones.

Monitoring radiation hazards it’s not a fun job, especially on FDA’s limited budget. Someone’s got to do it, though, or at least Congress thought so in passing the law. So FDA, already looking at cellphones as a radiation hazard, took a look at cellphones as medical devices and decided to… punt. FDA will treat apps according to their function and not their structure, letting the hardware itself basically off the hook.

I could give a dozen reasons why FDA might have made this decision, and a dozen more why it was the best result for public health. Getting to this decision, though, required the Center for Devices and Radiological Health to ignore the “RH” in its name and focus simply on its “D.” Walking away from part of its mandate is a Big Deal, and clearly a sign of an Agency that can focus on priorities.

So to me, the big news isn’t that we’ve now got a safe(r) harbor, since that always existed in practice. (If you ran FDA, where would you put your enforcement dollars: iPhone apps to remember your meds or fake cancer drugs made from saline?) The big news is that in the face of one of the biggest technological revolutions in history, FDA’s CDRH walked away from Radiological Health to focus on Devices.

Which is where they shine best.

And it’s where companies now find a safe harbor to innovate. Sometimes, government works.