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- Subpart B—Diagnostic DevicesCFR Sub-Part
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Ingestible Event Marker
- Page Type
- Product Code
- Definition
- To provide confirmation of an event co-ingested or coincident with the ingestible component of the device. The wearable component of the device incorporates wireless communication to display the event and other information on a general computing device
- Physical State
- The system is composed of an ingestible microsensor, a data recorder in the form of a skin patch, and software
- Technical Method
- The grain-of-sand sized microsensor is designed to communicate the time-stamped confirmation of dosing as a unique identifier to the Proteus ingestion recorder worn on the skin. The ingestion signal is communicated via volume conduction communication also known as intra-body communication. The IEM is attached to an inert pharmaceutical excipient tablet for ease of handling and swallowability.
- Target Area
- Digestive tract.
- Regulation Medical Specialty
- General Hospital
- Review Panel
- Gastroenterology and Urology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 880.6305
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 880.6305 Ingestible event marker
§ 880.6305 Ingestible event marker.
(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.
[78 FR 28734, May 16, 2013]