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U.S. Department of Health and Human Services

Product Classification

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Device implantable radio frequency transponder system
Regulation Description Implantable radiofrequency transponder system for patient identification and health information.
Definition An implantable microtransponder system intended to facilitate access to identification and health information in humans.It is described as consisting of a small implantable electronic microtransponder, an insertion device (introducer), and an electronic scanner (pocket reader).The microtransponder is a passive device that contains an electronic circuit, which is activated externally by a low-powered radio beam sent by a handheld, battery-powered pocket reader.The microtransponder stores only a unique electronic identification number (id).The id number is used to access a database that provides the implanted person's identity and health information supplied by the patient.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeNRV
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type 510(K) Exempt
Regulation Number 880.6300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    Note: Class II devices the Food and Drug Administration (FDA) has also published a list of Class II (special controls) devices subject to certain limitations, that are now exempt from the premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet a requirement of the Modernization Act.
Guidance Document
  • Class II Special Controls Guidance document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information - Guidance for Industry and FDA Staff
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible