---
kind: "section"
citation: "21 C.F.R. § 880.6300"
title: "21"
number: "880.6300"
heading: "Implantable radiofrequency transponder system for patient identification and health information."
url: "https://uscodex.org/cfr/21/880.6300"
---

# §880.6300. Implantable radiofrequency transponder system for patient identification and health information.

- (a) **Identification.** An implantable radiofrequency transponder system for patient identification and health information is a device intended to enable access to secure patient identification and corresponding health information. This system may include a passive implanted transponder, inserter, and scanner. The implanted transponder is used only to store a unique electronic identification code that is read by the scanner. The identification code is used to access patient identity and corresponding health information stored in a database.
- (b) **Classification.** Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information.” See [§ 880.1(e)](/cfr/21/880.1.md?p=e) for the availability of this guidance document. This device is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 880.9](/cfr/21/880.9.md).

## Notes

### Amendments

[69 FR 71704, Dec. 10, 2004]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 45 FR 69682, Oct. 21, 1980, unless otherwise noted.

### Amendments

[69 FR 71704, Dec. 10, 2004]