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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR880.6305]
See Related Information on Ingestible event marker. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 880 -- GENERAL HOSPITAL AND PERSONAL USE DEVICES

Subpart G--General Hospital and Personal Use Miscellaneous Devices

Sec. 880.6305 Ingestible event marker.

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.


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