By Bradley Merrill Thompson, Partner, Epstein Becker & Green

(I would like to thank John Murray of FDA, Scott Thiel of Roche Diagnostics and Russ Gray of the Anson Group for their comments on a draft. The views expressed -- right or wrong -- are only the author’s and should not be attributed to the commenters.)

Most people in the wireless health industry have heard by now that FDA has started to clear applications for cell phones with medical indications. A widely-reported example is AirStrip OB, cleared to deliver patient waveform data — including fetal heartbeat and maternal contraction patterns — in virtual real-time directly from the hospital labor and delivery unit to a doctor's mobile wireless device, specifically to an iPhone or a Blackberry. Other software developers are probably interested to learn when FDA clearance is required, and what it takes to accomplish that FDA clearance. In this article, I'll address both of those questions at a high-level.

This article is part of a series, and in the first article I outlined the factors FDA considers generally when deciding which products need to be regulated and which fall outside of the scope of a medical device regulation. In the second article, I outlined the basic steps for getting a medical device cleared by FDA. This article will focus on the unique aspects of those two questions in the context of mobile device apps.

Software Roles

From those two prior articles, it's important to remember that medical devices, including software, can be divided into three categories: (1) standalone devices, (2) accessories and (3) components. Standalone are those devices that are intended to directly provide the diagnostic or treatment, while accessories are sold directly to end-users and work with standalone devices. Components, in contrast, are purchased by manufacturers of standalone or accessory devices for incorporation before sale. Mobile device (e.g. cell phone apps) can be an accessory, as opposed to a component, if they are sold or even given directly to the end-user: the patient. They can also be standalone if they do not connect physically or virtually to any device other than the mobile device platform.

Understanding that is important because determines the regulatory requirements that apply. If the app is designed, for example, to facilitate the downloading of information from a blood glucose meter, the app and maybe even the software environment are accessories and will be regulated in the same manner as the blood glucose meter. The classification and most of the requirements for the submission to FDA will be dictated by how the parent standalone device is regulated. So, the Airstrip OB app is regulated as part of a perinatal monitoring system generally, just as the sensors and other hardware that gather the information.

Some apps will not be simply enablers of transmitting data from a medical device, but will actually serve a standalone purpose. From the prior two articles, remember that it's the claims the software developer/seller choose to make, within reason, that triggers FDA regulation in the first place, and the degree of that regulation when it comes to obtaining clearance.