FDA will actively regulate only the small portion of mobile medical applications that present the same risks as FDA-regulated conventional devices, the agency affirmed in the much-anticipated mobile apps final guidance (PDF) issued Sept. 23.
Sticking to a policy outlined in its 2011 draft guidance, the agency will apply enforcement discretion to a long list of lower-risk app types, even if they might technically meet the definition of a medical device. ...
Bradley Thompson, a lawyer with Epstein Becker and Green who heads the mHealth Regulatory Coalition, told "The Gray Sheet," the group is "delighted" FDA published the guidance within the timeframe promised to Congress.
"There is much that is very helpful in this guidance document, and we are particularly pleased that FDA is looking for innovative ways to communicate on a more ongoing basis the kinds of technologies that are regulated, and the kinds that are not," he said.
He said the final guidance is similar to the proposed guidance and still "omits some very important areas." In particular, he said FDA has not addressed the definition of what are regulated, disease intended uses compared to unregulated, wellness intended uses, as well as the exact meaning of an "accessory to a medical device," in the final guidance.
"But we also understand that FDA is working on those two topics separately so we look forward to seeing what the agency comes up with," he added.