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 Releases Final Mobile App Guidance, Reserves Oversight for High-Risk Products.”
Following is an excerpt:
The Food and Drug Administration Sept. 23 released long-awaited guidance to software developers signaling it would not regulate most mobile medical applications, instead reserving its authority for those products that meet the definition of a medical device and pose significant risks to patients. ?…
Attorney Bradley Merrill Thompson, with Epstein Becker Green in Washington, and one of the organizers of the mHealth Regulatory Coalition, told Bloomberg BNA that mobile health application developers would benefit from the clarity the FDA provided in the final guidance.
“We will all benefit from FDA’s efforts to deregulate a very substantial chunk of mobile apps that might otherwise have qualified for FDA regulation,” Thompson said.
He noted, however, that the guidance did not address two areas where developers have sought clarity. Thompson said the FDA did not clarify the differences in definitions for regulated intended uses of mobile apps for treating and diagnosing diseases and unregulated intended uses for wellness purposes.
Nor did the guidance provide “the exact meaning of an accessory to a medical device.”
“But, we also understand that FDA is working on those two topics and separately, so we look forward to seeing what the agency comes up with,” Thompson added.
Thompson also said the FDA in the final guidance gave “little attention” to clinical decision software and how it might seek to exercise oversight authority on those products.
“FDA appropriately extracted this issue out of the guidance document to put on a separate track,” Thompson said. Instead of this guidance, he explained, the FDA will take up clinical decision support software regulation as part of joint discussions with the Office of the National Coordinator for Health Information Technology and the Federal Communications Commission as part of their work under the FDA Safety and Innovation Act (FDASIA). ?…
Thompson said his discussions with FDA leaders indicate the agency will not seek to ambitiously enforce medical device requirements on mobile apps developers, but rather will work with developers to comply with FD&C Act mandates.
“Thus, if for example a company already has an app on the market that is within FDA regulation but the company has not taken steps to comply, it’s my impression that FDA will want to work with that company over a period of time to allow them to come into compliance, perhaps without requiring them to exit the market,” he said.