Classification for mHealth devices could simplify FDA regulation

Developers with the mHealth Regulatory Coalition may have done some important heavy lifting in the struggle to clarify the U.S. Food and Drug Administration's regulation of mobile devices.

The coalition used the FDA's existing classification system (Class I, II and III) for medical devices and applied it to the "miscellaneous" device category where most mobile devices fall. To date, most mobile software hasn't been clearly designated into the different risk classes, making it difficult for developers and users alike to know which technologies require FDA approval.

It's at the heart of their third installment in a three-part guidance document, just released last week. The document lays out how the industry thinks mobile device software should be regulated and approved, FDA regulatory expert Bradley Thompson, an attorney with Washington-based Epstein Becker Green, tells FierceMobileHealthcare.

For example, based on the FDA's existing Class II designation for "glucose test systems," the coalition created a category of "diabetes health management" devices that collect, monitor and analyze patient data. The new category is listed as a Class II, to conform to the FDA's existing precedent, Thompson explains.

The coalition had less to work with in creating its "physical therapy health application," he adds. But group members evaluated the risk of PT apps and software, largely designed to help patients improve mobility and flexibility (rather than affecting an significant internal body system), and settled on a Class I designation.

Unlike diabetic monitoring devices that "influence how much insulin a person takes ... these PT products are influencing how much pressure the patient will exert during a PT exercise. It's basically managing exercises, and is relatively low-level risk," Thompson tells us.

The FDA's own guidance is expected out in late summer or early fall, and the coalition plans to submit its new classification system for incorporation into the FDA's approach, he says.

This month, the group also is creating another resource document to inform FDA's process -- a written protocol explaining exactly how the group analyzed and assigned risk in their guidance document. The idea: To help FDA officials understand the algorithms, scientific theory and other factors that the Coalition used to slot mHealth devices into different categories.

In an unusual move, the coalition will join the American Telemedicine Association and Continua Health Alliance for an open meeting on July 27 in Washington, D.C., to request industry comments on the new proposal.

To learn more:
- read the MRC draft software guidance
- learn more about the MRC process
- get more detail on the FDA's plans

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New coalition to offer FDA guidance on regulation of mobile smartphone apps
FDA guidance on smartphone apps not likely until end of 2011