Does the New FDA mHealth Guidance Provide Clarity?

On September 23, 2013, the mHealth community finally got what they had been waiting for: the Food and Drug Administration’s (FDA) official Mobile Medical Applications Guidance.  Two years after releasing its initial draft guidance, the agency, acknowledging that the burgeoning industry is in need of regulation, made the final document available to the public.

“The Food and Drug Administration recognizes the extensive variety of actual and potential functions of mobile apps, the rapid pace of innovation in mobile apps, and the potential benefits and risks to public health represented by these apps,” the introduction reads.  But just how helpful is this new guidance?   In a recent editorial, Fierce Mobile Healthcare’s Greg Slabodkin offered a decidedly mixed review of the finished product. Although at first glance “the result was a bit anticlimactic,” Slabodkin also believes “app developers looking for an FDA communication that goes beyond its July 2011 draft guidance on mobile medical apps may not be disappointed.”

One definite positive: The agency did, Slabodkin notes, stay quite true to its initial guidance when it developed the current document, particularly with regards to its approach to app regulation.  “In announcing its final guidance, the FDA said it received more than 130 public comments on its draft guidance and that ‘respondents overwhelmingly supported the FDA’s tailored, risk-based approach’ to mobile medical apps,” he writes.  “So, it’s not surprising that the agency’s guidance has essentially remained the same.”  Slabodkin also approves of the “clarification” provided with respect to the agency’s “exempting borderline apps under its enforcement discretion authority,” which will greatly help app developers.

Yet the new guidelines also raise a series of new questions.  Slabodkin also questions the FDA’s note that the document “contains nonbinding recommendations.”  Though the agency does clarify later on that its guidance is not actual law, Slabodkin worries that “oftentimes [such wording] may be too subtle for lay people like myself to discern.”

mHealth Regulatory Coalition General Counsel Bradley Thompson, speaking to Slabodkin, also expressed some concern about the added content:  “An awful lot of the language in the final guidance document is new, which means it has not been publicly vetted before,” he explained, adding that “some of it is subject to interpretation and a bit confusing.”  The bottom line, it would seem, is to always consult an attorney when in doubt.

Click here for the article from Fierce Mobile Healthcare on the FDA’s Mobile App guidance.


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