Countdown to final FDA apps guidance has begun

If the FDA is true to its word, then according to my calendar the regulatory agency has 21 days left to fulfill its promise of issuing final guidance on mobile medical applications by the end of fiscal 2013. Back in May, I interviewed the FDA's Bakul Patel, the primary author of the agency's July 2011 draft guidance on mobile medical apps. At the time, Patel said that getting the final guidance out was a "top priority" and that they were working "expeditiously" to release it this fiscal year.

As we enter what is presumably the homestretch of a more than two-year odyssey, the FDASIA Workgroup last week released its report to ONC's Health Information Technology (HIT) Policy Committee with its own recommendations on the FDA's regulations. The FDASIA group has joined a chorus of mHealth stakeholders who have called on the FDA to issue its final mobile medical apps guidance as soon as possible.

"FDA should expedite guidance on HIT software, mobile medical apps and related matters," stated the report, which includes "current regulatory frameworks, potential new approaches and deficiencies, ambiguities and duplication in current frameworks." 

The FDASIA report describes what it believes "will be helpful to promote innovation in both the short and long term and maintain patient safety." Among the main issues that the report says the FDA needs to address in terms of mHealth: the regulatory agency needs to define the levels of risk for mobile devices and their accessories and determine which require regulating and which necessitate enforcement discretion.

"The FDA has a long-standing rule which says that anything intended to be used as an accessory to a medical device is itself a medical device and regulated to the same level as the device it accessorizes," states the report. "But there are many generic, low-risk accessories that should not take on the regulatory classification of the product it is intended to accessorize. More specifically, we need new accessory classifications that 'down classify' these accessories (i.e., lessen the classification) in much the same manner that FDA created the [Medical Device Data Systems] classification."  

We can all agree that app developers need a clear, predictable, and reasonable understanding of the FDA's current thinking on how it wants to regulate mHealth. The problem is that in the absence of final FDA guidelines--clearly two years has been too long to wait--the agency has created an environment of ambiguity and misinformation. Nevertheless, all along, the FDA has repeatedly stated for anyone willing to listen that their final guidelines will only apply to a small subset of mobile medical apps that pose the greatest risk to patients and meet the agency's definition of medical devices or are used as accessories to medical devices.

Nicholas Genes, an emergency room physician and assistant professor at the Icahn School of Medicine at Mount Sinai in New York City, was recently quoted in a syndicated article on mobile medical apps that appeared in newspapers around the country, capturing what I believe is a collective wish from all of us mHealth observers as to what the FDA's finalized guidance should ultimately achieve. "What everyone wants is reasonable regulation," said Genes. "We just want the FDA regulations to make sure that these apps are safe, secure and work well. It would be great if the FDA regulations didn't produce a big barrier to entry (and) small businesses didn't have to pay high or unreasonable fees." To which we say: Amen. - Greg (@Slabodkin