Amendment(s) published May 16, 2013, in 78 FR 28734
Effective Dates: June 17, 2013
2. Add § 880.6305 to subpart G to read as follows:
(a) Identification. An ingestible event marker is a prescription
device used to record time-stamped, patient-logged events. The ingestible component links wirelessly through intrabody communication to an
external recorder which records the date and time of ingestion as well as the unique serial number of the ingestible device.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) The device must be demonstrated to
be biocompatible and non-toxic;
(2) Nonclinical, animal, and clinical testing must provide a reasonable assurance of safety and
effectiveness, including device performance, durability, compatibility, usability (human factors testing), event recording, and proper
excretion of the device;
(3) Appropriate analysis and nonclinical testing must validate electromagnetic compatibility performance,
wireless performance, and electrical safety; and
(4) Labeling must include a detailed summary of the nonclinical and clinical testing
pertinent to use of the device and the maximum number of daily device ingestions.