US legislators are preparing to once again examine the US Food and Drug Administration's (FDA) approach to the regulation of mobile medical applications, this time focusing on its recently released final guidance document which calls for a risk-based approach.
Under the Federal Food, Drug and Cosmetic Act (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 affect 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."
Thus, because some of the applications are intended to be used "in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease," they are regulated as medical devices.
In 2011, FDA released a draft guidance document, Mobile Medical Applications, with the intent of clarifying some of the numerous questions surrounding its enforcement approach. FDA explained in the draft guidance document that it does not intend to regulate some health applications, namely those applications that merely serve to record basic health functions (such as weight or caloric intake) but are not otherwise involved in disease-specific functions.
On 23 September 2013, FDA released the final guidance on mobile apps that generally adhered to its previous framework. However, the guidance added an extensive appendix of examples, frequently asked questions (FAQ) and other resources, all meant to clarify what FDA will-and just as importantly, will not-regulate.
FDA said in a statement that it intends to "focus its oversight on mobile medical apps" that:
- are intended to be used as an accessory to a regulated medical device - for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet
- transform a mobile platform into a regulated medical device - for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.
Despite FDA's insistence that it will take an approach that is based on the inherent risk of the products, some legislators have expressed concern that FDA's authority is too vast and needs to be reined in.
In early 2013, for example, some legislators asked if FDA had the power to regulate the smartphone devices on which a mobile health application was run, or even the online "app stores" in which they were sold. FDA's Christy Foreman claimed the agency had no desire to regulate either in March 2013 testimony before the House Energy and Commerce Committee.
Then, in October 2013, Rep. Marsha Blackburn (R-TN) introduced the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act to explicitly ban FDA from regulating certain products under a new definition of "medical software."
Under the act, FDA would be banned from using its "enforcement discretion" on clinical or general health software, and would instead be granted authority only over an explicit set of software.
The law would, in effect, take FDA's current final guidance and turn it into binding statute, thereby removing FDA's ability to alter it at a later point in time.
Hearing on Mobile App Regulation
A 19 November 2013 hearing is now set to examine both FDA's final medical app guidance and the SOFTWARE Act.
The hearing, entitled "Examining Federal Regulation of Mobile Medical Apps and Other Health Software," will hear testimony from FDA's Director of the Center for Devices and Radiological Health (CDRH) Jeffery Shuren and a host of other panelists mostly hailing from industry.
While the background memo is short on details regarding potential questions, the hearing will likely be focused on making the case for the need or appropriateness of the SOFTWARE Act, which is sponsored by several members of the Energy and Commerce Committee.
"The bill would create regulatory certainty by giving FDA a new tool to regulate some forms of these emerging technologies without regulating them as medical devices," the notice argues.
Shuren, then, will be placed in something of a difficult situation. While the legislation is mostly in line with the intent of FDA's guidance, it would take away some authority from the agency to go after apps in the future if they harm consumers. Arguing against giving up that authority could be a hard sell in the Republican-controlled House committee, which has frequently expressed its gripes with Shuren in recent years over the speed of approvals and its approaches to regulation.
Editor's note: As Darius Tahir, editor at The Gray Sheet, helpfully points out, the SOFTWARE Act also regulates more than just medical apps. It also regulates medical software in general, including those bundled with medical devices and intended to diagnose patients. Please see Focus' original piece on the act to read the full definition.
E&C Hearing Notice