The release of the final mobile medical apps (MMA) guidance marks an important step forward on a decision that has been put on hold for more than two years. Those of us who have been involved in the FDASIA Workgroup on Health IT and pushing for the release of the landmark guidance are obviously delighted that FDA chose to go forward with publishing the guidance. This action shows both courage and a genuine desire to promote innovation.
Although much of the document is carefully crafted, some of the language remains subject to interpretation and is a bit confusing. These ambiguities will likely be worked out; however, they don’t seem to be very fundamental right off the bat. That said, the guidance is important because it aims to provide clarity in the muddled mobile medical app landscape and outlines a distinct framework for the future of this innovative sector.
The guidance also stands out because it represents a significant deviation from FDA’s standard approach to comments. Typically, FDA reviews comments submitted by a dozen or so institutions and then makes relatively minor modifications to the language prior to finalizing the guidance document. In this case, however, FDA made sweeping changes to the draft guidance in response to the scores of submitted comments. In a welcome move, the agency demonstrated that it thoroughly reviewed and considered submitters’ concerns and questions.
FDA says that, while it will be regulating apps, it will not be regulating retails like the Apple App store or Google Play.
But while refreshing, this deviation from the norm does create a conundrum of sorts. A great deal of the language in the final guidance document is new, which means that it has not been publicly vetted prior to finalization. One such example is FDA’s handling of the exemption of borderline apps under its enforcement discretion authority. Initially addressed only in footnote 13 of the draft guidance, this topic merited six pages of text in the final guidance. This elucidation on the subject is a wonderful development for industry, though, because it really is clarifying what was previously confusing, and perhaps even expanding on the idea. Plainly, there are a lot of apps that, in FDA’s mind, might qualify as a medical device but simply don’t warrant the time and resources necessary for active regulatory oversight owing to their relatively low-risk status.
Perhaps the best news of the day, however, is that the mobile medical apps guidance won’t be a static document. FDA is implementing a system for receiving questions about the scope of its regulation of mobile medical apps and subsequently posting answers for all to see on a dynamic webpage. This announcement is incredibly important because the mobile medical app world moves at such a fast pace that the notice and comment-style of guidance development could not possibly keep up with the constantly changing and evolving market. Now, obviously, there might be an issue if FDA were to take a conservative view of what, exactly, is subject to regulation. But every current indication points to FDA’s desire to be as hands-off and deregulatory in nature as possible without compromising patient safety.
Questions do still remain, however. In a briefing for stakeholders, FDA spoke about its plan for moving forward on the clinical decision-support software issue. This is a crucial issue that was given little attention in the final guidance by design. FDA appropriately extracted this issue from the guidance document to put on a separate track; the agency intends to pursue this particular issue through the discussions among FDA, FCC, and ONC as a part of the FDASIA section 618 process. Dr. Jeffrey Shuren, director of the center for devices and radiological health (CDRH), indicated that the likely output would be some sort of proposal in January 2014. The proposal might be specific, or it might identify a range of issues. But in any event, FDA signaled a clear intention to solicit further input after the first of the year when it has completed the agency discussions.
So, what’s next?
One of the key issues ahead will be transitioning from this guidance development phase to an enforcement phase. When asked about the agency’s plans for enforcement, Dr. Shuren was understandably very measured in his comments. He explained that FDA does not have an ambition to collect scalps—my words not his—but rather would like to work with companies that find themselves within the scope of FDA regulation.
Reading between the lines, it seems as though Shuren wants to start working with these outsider app companies in order to develop a plan for compliance. Thus, if an app developer unwittingly has a product currently on the market that should be regulated, it’s my impression that FDA will be willing to work with the company over a period of time to allow them to come into compliance—perhaps without requiring them to exit the market. It likely depends, at least in part, on whether there’s a perceived risk to consumers using the app; FDA clearly supports regulation of high-risk apps.
Overall, today is a good day. The mHealth developers will benefit from having the clarity that this document creates while we all will benefit from FDA’s efforts to deregulate a very substantial chunk of mobile medical apps that might otherwise have qualified for FDA regulation. In going forward, it looks like there might be an effective mechanism for FDA on a more-real-time basis to give advice quite publicly on how it is applying its regulations. This action represents exciting progress not only on the mobile medical apps front, but also on FDA’s general outlook and approach to working with industry.
Brad Thompson will be further dissecting the final regulation of mobile medical apps and what it means for industry in a presentation on the topic at MD&M Minneapolis.