Medical devices; general hospital and personal use devices; classification of implantable radiofrequency transponder system for patient identification and health information. Final rule.
The Food and Drug Administration (FDA) is classifying the implantable radiofrequency transponder system for patient identification and health information into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information." The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.
D004582:Electronics, Medical / Q000145:classification* / Q000295:instrumentation / Q000331:legislation & jurisprudence; D004867:Equipment Design / Q000145:classification; D004869:Equipment Safety / Q000145:classification; D006801:Humans; D008499:Medical Records; D010355:Patient Identification Systems / Q000145:classification* / Q000331:legislation & jurisprudence; D011845:Radio / Q000145:classification* / Q000295:instrumentation / Q000331:legislation & jurisprudence; D014481:United States; D014486:United States Food and Drug Administration