FDA Proposes Update To mHealth Rule

This week the FDA published a proposed rule updating how the agency would classify those devices.
 
Appearing on March 25 in the Federal Register, the 52-page document basically clarifies the process by which the FDA would classify medical devices – an action required under the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), which amended sections of the earlier Federal Food, Drug and Cosmetic (FD&C) Act. That amendment enabled the FDA to reclassify medical devices by administrative order instead of regulation.
 
According to the proposed rule, the FDA is offering "these revisions to update its regulations to reflect these and other changes, and to ensure classification of devices in the lowest regulatory class consistent with the protection of the public health and the statutory scheme for device regulation."
 
According to a National Law Review article written this week by Lynn C. Tyler and Hae Park-Suk of Barnes & Thornburg, LLP, the proposal would place regulated medical devices into five categories, with the FDA keeping track of devices that would: