US regulators have moved in recent years to better define their approach toward the regulation of so-called "mobile medical applications," or just "apps," available on smartphones and tablet devices. But that regulatory framework could soon be dismantled if a Republican legislator on the House Energy and Commerce Committee is successful in passing a piece of soon-to-be-proposed legislation.
Appearing this weekend on Fox News, Tennessee Rep. Marsha Blackburn (R) told Fox's Shannon Bream that she and other legislators were concerned that FDA's treatment of mobile medical applications and the devices that run them as medical devices has the potential to subject the products to taxation. Under the Patient Protection and Affordable Care Act (PPACA), better known as "Obamacare," most medical device products are subject to a 2.3% medical device excise tax. Exempt from the tax are those devices available to consumers in retail environments-"generally purchased by the general public at retail for individual use."
FDA already regulates so-called mobile medical applications under a framework it published in the form of a draft guidance document in 2011.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 and subsequent legislation. 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FDA's regulatory framework, as currently proposed in the 2011 draft guidance document, explains that FDA intends to regulate any applications that make specific disease or curative claims.
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.
But could a tablet or smartphone be considered a medical device as well? FDA already regulates software and the medical devices on which they run, and considers them to be Class I medical devices requiring premarket notification. It has yet to weigh in on whether it considers a smartphone or tablet to be a medical device, though it already has the authority to regulate products that are used as an accessory or component part to a medical device. One might argue that when running a mobile medical application, a smartphone or tablet is rendered into a medical device.
Those concerns-that FDA could make the argument that a tablet, application or smartphone is a medical device-were the basis of a 4 March 2013 letter to FDA by Blackburn and US Reps. Fred Upton, Tim Murphy, Michael Burgess, Joe Barton and Greg Walden.
Legislators said based on past FDA interpretations of the definition of "medical device" as being predicated on its "actual use," they believed FDA might consider regulating all three, reducing incentives to invest in the burgeoning sector.
"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 if FDA chose not to regulate the devices using its enforcement discretion, a legal definition as a medical device could cause the devices to be subject to the tax if they are not subject to the retail exemption.
Could FDA's Regulatory Authority be in Jeopardy?
And that possibility has Blackburn and other conservative members of the Energy and Commerce Committee-the House committee charged with oversight of FDA's regulatory activities-concerned.
"We're going to do a hearing on this at Energy and Commerce very soon," Blackburn told Bream in a 10 March 2013 interview. "I have draft legislation that is coming out which would be an expressed prohibition, prohibiting FDA from getting into these mobile applications as a healthcare medical device."
Blackburn added that she was concerned that attempts to regulate the sector or tax it could endanger innovation in the sector, which she noted was growing quickly in hospitals and included new telemedicine methods.
Though the legislation has not yet been published, Blackburn's language indicates that FDA's draft guidance document-its regulatory framework for regulating mobile medical applications-could be in jeopardy under the law.
FDA has until 15 March 2013-this Friday-to respond to Blackburn's letter.