Final FDA guidance provides clarification and confusion

Well, it finally happened--the most anticipated mHealth event of the year. Yesterday, the FDA released its final guidance on mobile medical applications. On the surface of it, for a 43-page document that took the regulatory agency more than two years to complete, the finished result was a bit anticlimactic. However, upon closer review, app developers looking for an FDA communication that goes beyond its July 2011 draft guidance on mobile medical apps, may not be disappointed. 

A side-by-side comparison of the FDA's initial guidance and the agency's final/current "thinking" on how it plans to regulate mobile medical apps reveals them to be similar. In announcing its final guidance, the FDA said it received more than 130 public comments on its draft guidance and that "respondents overwhelmingly supported the FDA's tailored, risk-based approach" to mobile medical apps. So, it's not surprising that the agency's guidance has essentially remained the same since it was first proposed in July 2011 and released for public comment. But, there are certainly important differences as well between the draft and final guidance documents.

As the FDA states, it issued its final guidance to "provide clarity and predictability" for manufacturers of mobile medical apps. "People, and we heard this in our public meetings, wanted a lot more clarity. We heard that loud and clear," FDA's Bakul Patel, the primary author of the agency's guidance, told me in May when I interviewed him. Obviously, Patel and others at the regulatory agency took the public's feedback to heart when they finalized the FDA guidance.

A great example of this kind of clarification is the way in which the FDA's final guidance took the concept of exempting borderline apps under its enforcement discretion authority, including those apps that would "allow individuals to self-manage their disease or condition," and greatly expanded the amount of text dedicated to explaining its approach. "Basically this went from a footnote, footnote 13 in the original document, to a full six pages in the final guidance," said Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition, speaking to FierceMobileHealthcare yesterday. "This is a wonderful development for industry because it really is clarifying what was previously confusing, and perhaps even expanding on the idea."

Still, at the same time, Thompson admitted that "an awful lot of the language in the final guidance document is new; which means it has not been publicly vetted before." He warned that "while much of it is carefully written, some of it is subject to interpretation and a bit confusing." However, Thompson reassured me that "these issues will get worked out; they don't seem to be very fundamental."

I'm no lawyer but the fact that the agency's final guidance states in bold letters at the top of each page that it "Contains Nonbinding Recommendations" is confusing in and of itself. Sure, I've read the legalese in the final guidance that reminds readers that the document "does not establish legally enforceable responsibilities" and "should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited." Yet, oftentimes that may be too subtle for lay people like myself to discern. That's why we will continue to need the counsel of attorneys like Thompson to tell us what the FDA is thinking. - Greg (@Slabodkin)