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Medical Devices; General and Plastic Surgery Devices; Classification of the Internal Tissue Marker. Final order
Federal Register
|August 7, 2015
Abstract:
The Food and Drug Administration (FDA) is classifying the internal tissue marker into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the internal tissue marker's classification. 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.
