The FDA has now published its proposed rule simplifying its medical device classifications as directed by the 2012 FDA Safety and Innovation Act (FDASIA). This permits reclassification by administrative order versus the rulemaking (notice and comment) process. (Presumably this rule, as part of the latter process, sets up the process for the former.) In the US, the Food, Drug & Cosmetic Act (FDC Act), which FDASIA amends, has three classifications of devices from least restricted (Class I general controls) through premarket approval (Class III).
As published yesterday in the Federal Register, the class definitions are being amended to balance the assurance of safety and effectiveness with “the level of regulation necessary to provide such assurance should be closely tailored to the risk presented by a type of device.” The long-awaited changes are seen as highly favorable for mobile health devices and apps which for the most part do not fit neatly into the present Class I-III structure. There is new explanatory language for ‘general controls’ (I) and ‘special controls’ (II). The rule also clarifies five categories of devices to be included in the highest potential risk category, Class III. There are cheers from the usual quarters — Brad Thompson of the mHealth Regulatory Coalition, and more. Health Data Management. National Law Review. iHealthBeat (though Editor Donna cautions that the “lowest regulatory class” followed by the Class III five categories is misleading.)