{"data":{"id":"us/21-cfr-880.6300","jurisdiction":"us","citation":"21 CFR 880.6300","heading":"Implantable radiofrequency transponder system for patient identification and health information.","body":"(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.\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES","Subpart G—General Hospital and Personal Use Miscellaneous Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"e9f9e3987497f316eda21bbcfb418f5e1de149e119bf6789c361e57b77131413","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-880.6280","next":"us/21-cfr-880.6305"},"notice":"GroundRules: Original legal text. Not legal advice."}