21 CFR 880.6300
§ 880.6300 Implantable radiofrequency transponder system for patient identification and health information.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 880.6300, § 880.6300 Implantable radiofrequency transponder system for patient identification and health information, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90584
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.