Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled “FDA Plans to Use Enforcement Discretion on Low-Risk Mobile Apps.”
Following is an excerpt:
FDA laid out a more hands-off approach to its regulation of mobile medical applications in finalized guidance issued Monday (Sept. 23). The agency plans to regulate only those applications with functions similar to medical devices currently under FDA’s purview and use enforcement discretion on other low-risk applications, the agency’s top device official said. Issuance of FDA’s final mobile medical applications guidance comes on the heels of the publication of recommendations from a federal health information technology working group for a tri-agency, risk-based HIT framework and the FDA guidance tracks with the group’s suggestions for the agency to establish a policy of enforcement discretion and focus on the function of the applications. The agency plans to address other issues, like its regulation of clinical decision support software, in report that will be submitted to Congress in January. ?…
But Bradley Merrill Thompson, another member of the workgroup and general counsel to the mHealth Regulatory Coalition, said the agency also omitted other areas of key interest to stakeholders like providing a definition of an FDA-regulated mobile app, a description of the intended use for a regulated mobile app in comparison to unregulated medical apps, an explanation of what the agency would consider to be a wellness intended use, and also the exact meaning of an accessory to a medical device.
The guidance also creates an “interesting problem” in that it includes a lot of new language that has not been publicly vetted. While much of it is carefully written, some of it is subject to interpretation and is a bit confusing, Thompson said. Yet, he said he was confident those non-fundamental issues could be worked out and was generally pleased with the guidance.
“Overall, today is a good day,” Thompson said. “The mHealth developers will benefit from having the clarity that this document creates. We all will benefit from FDA’s efforts to deregulate a very substantial chunk of mobile apps that might otherwise have qualified for FDA regulation.”