(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 Sec. 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 Sec. 880.9. [69 FR 71704, Dec. 10, 2004]