CDRH’s Concept of Class IIb Devices Is Not What AdvaMed Had in Mind

The idea for a Class IIb subset for devices may have come from AdvaMed, but the trade group isn’t happy with how CDRH is shaping it. As AdvaMed conceived it, the Class IIb would be a limited subset of Class II devices that would be subject to enhanced pre- and postmarket requirements. But when CDRH embraced the idea, including it in a list of possible suggestions for improving the 510(k) clearance process, it went beyond AdvaMed’s concept, the trade group says in a comment on those suggestions.
Devices & Diagnostics Letter