An ingestible event marker is a prescription device used to record time-stamped, patient-logged events, the agency noted. The ingestible component links wirelessly through intra-body communication to an external recorder which records the date and time of ingestion as well as the unique serial number of the ingestible device. The decision to down-classify this type of device came in response to a May 2012 request from Proteus Biomedical to consider lowering the regulatory bar for its Proteus Personal Monitor including ingestible event marker into Class II.
The federal watchdog agency had originally ordered Proteus’ device be classified into the highest risk Class III because it was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or to a device which was subsequently reclassified into Class I or Class II. But, after reviewing information submitted in Proteus’ petition and the medical literature, the FDA determined that the Proteus Personal Monitor including ingestible event marker can be classified into Class II with the establishment of special controls, and on July 10, 2012, the FDA issued an order to Proteus Biomedical down-classified the device.
The FDA codified the classification of Proteus’ device today and has established that any firm submitting a 510(k) premarket notification for an ingestible event marker will need to comply with a number of special controls.
REFERENCE: May 17, 2013; Ingrid Mezo; Mass Device