# Medical Devices; General Hospital and Personal Use Monitoring Devices; Classification of the Ingestible Event Marker
> **Food and Drug Administration** · Final order. · Published 2013-05-16 · Effective 2013-06-17 · 78 FR 28733
## Document
- **Document number:** 2013-11628
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 78 FR 28733
- **CFR reference:** 21 CFR 880
- **Publication date:** 2013-05-16
- **Effective date:** 2013-06-17
- **HHS docket:** Docket No. FDA-2013-M-0042
## Abstract

The Food and Drug Administration (FDA) is classifying the ingestible event marker into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2013/05/16/2013-11628/medical-devices-general-hospital-and-personal-use-monitoring-devices-classification-of-the)
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