The Food and Drug Administration said Monday it's planning two public meetings in September to address some headline-grabbing recent announcements.

The first meeting, slated for Sept. 12-13, will tackle the agency's draft guidance on medical applications for smartphones and other mobile devices. The second, on Sept. 16, will address the Institute of Medicine's recent controversial report that recommended scrapping the 510(k) device clearance process.

At the first meeting, set to be held on FDA's campus in Silver Spring, Md., the agency is specifically asking how it should approach mobile medical apps that serve as accessories to other devices, and clinical-decision-support software.

The meeting follows the release last month of the agency's mobile app guidance, in which the FDA outlined the type of mobile applications it would seek to regulate. Broadly, medical textbooks and general wellness apps would not fall under review; apps that "transform" smartphones or tablets into a medical device would. Examples given by the FDA include programs that control an insulin pump, display medical images from a PACS server or use algorithms to make treatment recommendations. Even if you can't attend the workshop, the FDA's accepting comments on its proposal until Oct. 19.

In the second meeting, to be held at the Silver Spring Hotel, the FDA's asking for feedback on the IOM's divisive report on the FDA's 510(k) process, which came out at the end of last month. The report recommended scrapping the 35-year-old process used by the agency to bring moderate-risk devices, including most imaging equipment, to market. Though praised by many patient advocates, the institute's findings drew heavy criticism from medical device manufacturers and even some Midwestern politicians .

More Industry Headlines