This is a topic I have been following for awhile now and would like to share with you folks, an update I got off mHealthNews;
Congressional pressure notwithstanding, the U.S. Food and Drug Administration is forging ahead with plans to regulate mobile medical devices. 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:
- Show uncontrollable known risks;
- Display an unknown or unfavorable risk-benefit profile
- Require a complete review of manufacturing information;
- Require pre-market review for changes affecting safety or effectiveness; and
- Include a drug or biological product that must be reviewed for safety and effectiveness.
The FD&C Act had established three categories for the regulation of medical devices: Class I (General controls), Class II (special controls) and Class III (pre-market approval). With the growth of mHealth and the proliferation of mobile medical devices and apps, however, it became clear that federal regulators would have to be more specific in what they could govern.
“(The) FDA proposes to amend the definitions of class I, class II, and class III by revising the definitions to reflect a key principle underlying device classification, namely, that a reasonable assurance of safety and effectiveness is necessary for all three device classes; however, the level of regulation necessary to provide such assurance should be closely tailored to the risk presented by a type of device,” the proposed rule states. “Explanatory language about general and special controls has been removed from the definitions of class I and II, respectively, to avoid repetition with the new proposed definitions for the terms ‘general controls’ and ‘special controls.’ Other minor changes are intended to improve the clarity and structure of these definitions.”
The proposed rule follows recent attempts by Congress to closely control what the FDA regulates, with some lawmakers expressing fears that too much FDA control could hinder innovation in this fast-moving field. Others, however, have noted that the FDA and other federal agencies need to set clear standards to prevent the mobile app industry from becoming so unregulated that it could squash good innovation and potentially hurt or kill patients.
In published reports, Bradley Merrill Thompson, a Washington D.C. attorney and general counsel for the mHealth Regulatory Coalition, hailed the FDA’s proposed rule, saying current mHealth products “do not fit squarely into the old classification system.” He added that the FDA, through this new action, could “do a better job of keeping up with these important new technologies, providing clear guidance for the new categories of technology being developed.”
Public comment on the proposed rule ends on June 23.
The proposed rule can be found here.
Stay tune for the updates.