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Title 21 Part 880 → Subpart G → §880.6305

Title 21 → Chapter I → Subchapter H → Part 880 → Subpart G → §880.6305

Electronic Code of Federal Regulations e-CFR

Title 21 Part 880 → Subpart G → §880.6305

e-CFR data is current as of July 11, 2019

Title 21Chapter ISubchapter HPart 880Subpart G → §880.6305


Title 21: Food and Drugs
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart G—General Hospital and Personal Use Miscellaneous Devices


§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]