FDA's long-delayed release of the final mobile medical apps guidance may finally be within reach.
When it comes to apps and mobile phones, speed is everything. Unfortunately, FDA can’t keep up. The sector’s fast pace of innovation and product development stand in stark contrast to the snail’s pace of progress on final guidance for the regulation of mobile medical apps (MMA). But with innovation at stake, patient safety at risk, the FDASIA Workgroup’s recommendations in, and the deadline for final MMA guidance looming, it’s time FDA provided a clear pathway and picked up the pace.
Released back in July 2011, FDA’s MMA draft guidance represented significant progress toward outlining a risk-based regulatory framework for these diverse and innovative new technologies. More than two years later, the flourishing mobile health (mHealth) landscape has altered even more dramatically as legions of developers line up to cash in on the booming health and wellness trend.
And yet, the problems, questions, and concerns remain unchanged. To patients’, developers’, and the industry’s detriment, the release of a definitive guidance on the regulation of mobile medical apps has been delayed by a blend of bureaucracy, conflicting political agendas, and—to a lesser extent—issue complexity.
“Somehow, this instructive document, intended to lift the fog of ambiguity, created quite a controversy in Washington policy circles,” Robert Jarrin, Qualcomm’s senior director of government affairs, and FDASIA Workgroup member wrote in a recent post to the company’s blog. “Inexplicably, a number of groups vehemently opposed the issuance of the MMA guidance. They seemed to want to stifle FDA’s ability to issue any guidance while they worked to limit the way FDA regulates medical devices, in particular health IT, and not just mobile medical apps.”
Bradley Merrill Thompson, partner at Epstein Becker & Green, cochair of the FDASIA Workgroup’s regulation subgroup, and upcoming speaker on the subject of medical app regulation at MD&M Minneapolis, echoes this frustration. “[These groups] seem to want to freeze all forward progress at the agency until they’ve had time to get Congress to pass legislation that would presumably alter the landscape. I think that’s very shortsighted.”
Shortsighted, indeed. In the absence of definitive guidance, consistent enforcement, and a clear, risk-based regulatory framework for medical apps, a virtual free-for-all has occurred in the mHealth space. In particular, a lack of clarity around what, exactly, constitutes a medical device has been the source of much confusion as well as a loophole for many companies in the relatively nascent medical mobile app market. The definition of a medical device predates the emergence of app technology, after all, and its ambiguous nature leaves a lot of room for interpretation.
This ambiguity is particularly problematic considering that many app developers jumping on the medical, health, and wellness app bandwagon are outsiders unfamiliar with the regulated industry. Consequently, many developers either grapple with whether or not their technologies are subject to FDA review and what that entails or neither consider nor care about FDA regulation and compliance.
The result is an unregulated market abounding with apps that make unsubstantiated claims and mislead or potentially endanger consumers. “There are dozens—if not hundreds—of mobile apps that are on the market now that should have gone through the FDA clearance process,” Thompson states. “As to whether or not they’re dangerous or not, no one knows, right? The point of FDA review is to validate and make sure that products aren’t dangerous.”
Among the most notable apps to flaunt its seemingly medical device functionality is the uChek. Designed to convert a cell phone into a personal medical lab, the uChek caused a splash this past spring after a much-publicized TED talk explained how the app, in essence, performs urinalysis. Although most apps seem to be flying under FDA’s radar, the agency found it hard to ignore the high-profile app, and subsequently sent the company an “it has come to our attention” letter. The company later launched an unsuccessful crowdfunding effort on indiegogo to help pay for the 510(k) submission and other regulatory costs.
And while questionable apps are inundating the market, the introduction of truly innovative and potentially disruptive apps is somewhat stalled as savvy developers understandably proceed with caution. Thompson notes that companies whose apps fall into a gray area are hesitant to go to market because they don’t want to invest unnecessarily in compliance if they may not have to under the new guidance.
Furthermore, companies that are relatively certain that their apps will be subject to FDA review have pressed pause on development as they await clear guidelines that will tame the current Wild West app marketplace. “Even if a company understands it will be regulated, it doesn’t want to enter the space so long as FDA is not actively enforcing the rules against those entering without observing FDA standards,” Thompson says. “If FDA’s letting everyone go through, someone else could not pursue that costly activity and come to market with a 99-cent app and undercut [the legitimate company].”
The final guidance needs to clearly define when an app is a medical device and, thus, should be regulated; differentiate between a medical device app and wellness app; and avoid overregulation of low-risk apps. But to impose order among chaos and unfreeze the innovation pipeline, FDA needs to heed the advice of the FDASIA Workgroup and expedite final guidance. And fast. As of mid-September, the guidance has not been released; however, the September 30 deadline still lies ahead as a glimmer of hope. To reach that goal, though, FDA needs to act in the best interest of the public it serves and cut through the red tape in Washington. If only there were an app for that.