Is the US Food and Drug Administration (FDA) preparing to regulate your smartphone or tablet computer? And will mobile medical applications-apps-be subject to the 2.3% medical device excise tax? Republican members of the House Energy and Commerce (E&C) Committee are worried the agency isn't being clear enough, and have sent a letter to FDA Commissioner Margaret Hamburg seeking to clarify the agency's authority and other outstanding questions.
FDA already regulates so-called mobile medical applications under a framework it published in the form of a draft guidance document in 2011.
Its authority to do so comes at its most basic level from the Federal Food, Drug and Cosmetic Act (FD&C Act) as amended under the 1976 Medical Device Amendments. Under the FD&C Act, medical devices are defined as being any "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is either intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease or intended to affects the structure of any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body."
FDA's regulatory framework, as currently proposed in a 2011 draft guidance, explains that FDA intends to regulate any applications that make specific disease or curative claims, but will leave it to the Federal Trade Commission (FTC) to regulate all other applications. FTC issued guidance on the subject in September 2012.
Thus, an application like a fitness tracking application or a calorie-counting application would not, by itself, be considered a medical device under that framework. However, an application which claims that by following its regimen you can reduce obesity, or an application that claims to emit a frequency that can cure tinnitus, would both be considered a medical device under the FD&C Act and would be required to undergo a review process. Still, experts say it's a distinction that's not always easy to make, and it's more a question of agency resources than anything else.
Is a Phone a Medical Device?
But the ambiguities of the process also raise an important question: Is FDA's treatment of apps as a medical device limited to the app, or does it extend to the phone as well?
It's a question Regulatory Focus raised in August 2012 after a Government Accountability Office (GAO) report recommended that the Federal Communications Commission (FCC) ask FDA or the National Institutes of Health (NIH) to reassess the risks of radiation exposure from radiation-emitting devices such as cell phones. FDA had called for additional research on the same topic in 2001, the GAO report noted.
Should FCC choose to request such a review, it is within the realm of possibility that FDA could find some mobile phones emit too much radiation to be considered safe for consumers, particularly those using them for health reasons. Other considerations, such as the security of mobile applications, might also weigh on regulators' minds.
But even casting aside hypothetical radiation concerns, FDA already has the authority to regulate products that are used as an accessory or component part to a medical device. One might argue that an application is just lines of code without a device on which to run-in this case, a smartphone-and that, by extension, this would constitute a medical device. It should be noted, too, that FDA already regulates software and the medical devices on which they run, and considers them to be Class I medical devices requiring premarket notification. The Class I approach, established in February 2011, is actually a step up from before, when all novel software applications were automatically considered to be Class III (dangerous) unless they were substantially equivalent to an earlier piece of software.
What about Taxation?
This broader question of, "What is a medical device," seems to have raised the interests of legislators, whose letter makes note of their concerns.
"Will the actual use of a smartphone, tablet or app be a factor in whether the FDA chooses to regulate the device or app as a medical device?" asked the legislators. "Has it been a factor in any analysis by FDA already completed?"
While their concern may be partially predicated on their concerns of potential disruption of a burgeoning market for healthcare applications, they explained their main concerns actually have to do more with taxation.
Under the 2010 Patient Protection and Affordable Care Act (PPACA, 'Obamacare') medical device manufacturers are subject to a 2.3% excise tax on revenues from all medical devices sold. FDA has, in the past, contended that the "actual use" of a product determines whether or not it is a medical device, the legislators note. In that case, FDA was making the case that in vitro diagnostic (ICD) products would be assessed according to their "actual use," and not just their "intended use."
"If FDA decides to take a similar approach in its final guidance with medical applications, this could affect the growth and innovation in this market," the legislators wrote. By the same analysis, tablets and smartphones could similarly be subject to the device excise tax depending upon FDA's regulatory definition.
Even with FDA's enforcement discretion, a legal definition as a medical device could cause the devices to be subject to the tax.
Of particular interest to legislators was also the date by which FDA expects to have published its final guidance on mobile medical applications. In a statement in November 2012, FDA noted that it planned to release its final guidance in 2013, but did not specify when that would take place. The list is also by no means binding.
Regulators may be keen to hurry up and issue the guidance as well. FDA has been under fire from other legislators, including Rep. Mike Honda, who has called on the agency to establish an office of mobile medical applications to better coordinate regulatory expertise in the area.
FDA has also been grappling with an explosion in so-called "snake oil" applications, which are seen by some as scamming consumers with false or impossible claims. Barring a clear framework, some consumers could be injured or avoid seeking treatment based on faulty medical advice.
Even when the applications are web-established and cleared through the agency, other issues emerge. For example, how do you recall an application? Pfizer's Pocket.MD app may be the first such application to be recalled, but the area poses some unique challenges that could benefit from further guidance.
The E&C letter to FDA was signed by Reps. Fred Upton, Tim Murphy, Marsha Blackburn, Michael Burgess, Joe Barton and Greg Walden.