21 CFR § 880.6300 - Implantable radiofrequency transponder system for patient identification and health information.

---
identifier: "/us/cfr/t21/s880.6300"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 880.6300 - Implantable radiofrequency transponder system for patient identification and health information."
title_number: 21
title_name: "Food and Drugs"
section_number: "880.6300"
section_name: "Implantable radiofrequency transponder system for patient identification and health information."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "880"
part_name: "GENERAL HOSPITAL AND PERSONAL USE DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "45 FR 69682, Oct. 21, 1980, unless otherwise noted."
cfr_part: "880"
---


# 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) for the availability of this guidance document. This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

[69 FR 71704, Dec. 10, 2004]