FDA goes a bit easier on digital pill classification (US)

Good news for digital pill developers such as Proteus and Carnegie-Mellon’s digestible devices [TTA 15 April]. In FDA’s final order issued 16 May in the Federal Register, ‘ingestible event markers’ (IEM) are now classified as a Class II medical device, which does not require the premarket approval and the longer approval cycle that new devices (‘de novo’) under Class III must have. According to The Hill’s’ regulation blog ‘RegWatch’, “FDA granted the device class 2 status shortly after its approval in 2012, but the legal order sets a permanent standard for the technology.” Proteus’ FDA approval for their IEM was granted in July 2012 [TTA 2 Aug 12] and this now formalizes subsequent IEM classification. iHealthBeat