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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR880.6300]
See Related Information on Implantable radiofrequency transponder system for patient identification and health information. in CDRH databases



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

Sec. 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]

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