# Medical Devices; General Hospital and Personal Use Devices; Classification of Implantable Radiofrequency Transponder System for Patient Identification and Health Information
> **Food and Drug Administration** · Final rule. · Published 2004-12-10 · Effective 2005-01-10 · 69 FR 71702
## Document
- **Document number:** 04-27077
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 69 FR 71702
- **CFR reference:** 21 CFR 880
- **Publication date:** 2004-12-10
- **Effective date:** 2005-01-10
- **HHS docket:** Docket No. 2004N-0477
## Abstract

The Food and Drug Administration (FDA) is classifying the implantable radiofrequency transponder system for patient identification and health information into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information." 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. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2004/12/10/04-27077/medical-devices-general-hospital-and-personal-use-devices-classification-of-implantable)
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