21 C.F.R. § 880.6300

Current through September 30, 2024
Section 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 .

21 C.F.R. §880.6300

69 FR 71704, Dec. 10, 2004