FDA Withdraws Proposal to Tighten Control on Cranial Electrotherapy Devices

The Food and Drug Administration is backtracking on a proposal to reclassify into class III and require premarket approval for cranial electrotherapy devices. The agency is withdrawing a proposed order from April to reclassify the devices, which are used to treat insomnia, depression and anxiety (see 13040420). Instead, it plans to issue a proposed order to reclassify cranial electrotherapy devices into class II, which means they may require premarket notification but not premarket approval.