Federal Register Final order: FDA is classifying the ingestible event marker into Class 2 (special controls) in order to provide a reasonable assurance of safety and effectiveness for the device. It is a prescription device used to record time-stamped, patient-logged events. The ingestible component links wirelessly through intrabody communication to an external recorder that records the date and time of ingestion as well as the unique serial number of the ingestible device. To view this final order, click here.