This morning the US Food and Drug Administration offered up a set of draft guidelines for how it might regulate certain mobile medical apps. While this set of guidelines was years in the making, it became clear a few months ago that the FDA would publish draft guidelines around this time. The FDA is seeking comments on these guidelines between now and October 19. This FDA guidance does not cover wireless safety considerations, classification and submission requirements related to clinical decision support software, or the application of quality systems to software -- these may be addressed through other guidances in the future, however.
"We are focusing on what we think we should be focusing on,"Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health at the FDA, told Babyforyou.net.ua in an interview yesterday. "If something is to change in the future, then we would go out and put out a new policy and get comment but as of right now that is not what we are anticipating to do. These are the devices we have been regulating all along and just because they are on a mobile platform doesn't mean we should be regulating differently."
As part of its draft guidance the FDA, of course, had to sketch out its very particular definition of a mobile medical app. The agency broke the definition into three parts: mobile platform, mobile app, and mobile medical application. A mobile platform is a commercial off-the-shelf computing platform "with or without wireless connectivity" that is handheld. Mobile apps are software that can be run on a mobile platform or a Web-based software application that is designed for the mobile platform. Finally, a mobile medical app is one that meets the definition of "device" according to the FD&C Act, but for this set of draft regulation it also must be "used as an accessory to a regulated medical device" or it must "transform a mobile platform into a regulated medical device."
Among the apps that fall outside of the FDA's definition of a mobile medical app, there may be some that do fall under the broader definition of a medical device. "Right now we are only interested in those mobile medical devices that fall into this definition. We are starting off with the very small tip of the pyramid," Bakul Patel, policy advisor at the FDA's CDRH, told Babyforyou.net.ua. "The bottom of the pyramid might include health and wellness apps. The middle of the pyramid may include some health and wellness and pure medical apps. At this time, however, those are not of interest." That's not to mean the FDA won't regulate these other apps in the future.
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The FDA also points out that some of the mobile platform's "unique characteristics" are reasons why mobile medical apps may "pose additional or different risks." Patel told Babyforyou.net.ua that the devices' smaller screen size and lower contrast ratio are the "obvious" concerns -- particularly for interpretation of radiological images on a mobile device. Uncontrolled ambient light from the device is another characteristic that could create risks, according to the draft document. Patel also said that "one of the unique characteristics of the mobile platform is the user." Patel pointed to an example of an EKG device that is attached to a mobile phone -- "it has electrodes which are designed to be used in a clinical setting" so "when a regular patient is using a device like that it brings in a whole new set of human factors that need to be considered," he said. The FDA plans to keep these limitations in mind as its continues to develop oversight guidelines for medical apps.
Interestingly the FDA laid out some examples of the types of apps that would not be subject to the draft regulations as well as a number of apps that would fall into them. Be sure to read our writeup of these two groups: Apps that would not be regulated and Apps that would be regulated.
Comments sought on Accessory Rule
"The FDA has typically expected that the manufacturer of an accessory would meet the requirements associated with the classification of the connected device," the document reads. "However, this approach may not be well-suited for mobile medical apps that serve as an accessory to another medical device because of the wide variety of functions mobile medical apps can potentially perform. Therefore, FDA is seeking comment on how it should approach mobile medical apps that are accessories to other medical devices so safety and effectiveness can be reasonably assured."
AppStore operators and mobile phone makers are off the hook
The FDA makes clear in a couple of sections of the draft document that mobile medical app distributors (app stores) and mobile platform manufacturers (handset makers) that do not engage in manufacturing functions of the mobile medical app do not have to go through the regulatory steps. This is true, of course, even though the device or appstore might be supporting the medical app. "For example, if it is possible to run mobile medical apps on BrandNamePhone but BrandNamePhone is not marketed by BrandNameCompany with a medical device intended use, then BrandNameCompany would not be a medical device manufacturer," the document reads. When asked, Patel said that Apple's commercials, which show the iPad running MIM's imaging diagnostic app may be crossing into a "grey area" but that's not something the FDA is looking to create new guidance on with this set of draft regulation. Patel said, however, that the agency would welcome additional feedback on where it should draw that line.
Small chance draft guidelines will not progress further
While the FDA's draft guidelines for mobile medical apps are an important development, it is possible that the FDA won't take the regulations any further -- that's happened before, anyway. In 1989 the agency prepped a policy statement on how it planned to regulate computer-based products and software, which was known as the "Draft Software Policy." Since the use of computer and software products accelerated so quickly, however, and the types of these devices grew "exponentially" the FDA decided it wasn't practical to create guidelines that would address all medical devices containing software. So those draft guidelines were withdrawn.
It's clear that the FDA's narrow focus in this draft document is intended to whittle down the exponentially growing world of medical apps. Both Patel and Shuren were confident that this set of draft guidelines would not meet the same fate as the Draft Software Policy.