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Author Spotlight: Advancing Prostate Cancer Research Through Improved Tissue Sampling and Biobanking
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Medical Devices; Gastroenterology-Urology Devices; Classification of the Prostate Lesion Documentation System.
Federal Register
|November 25, 2015
Abstract:
The Food and Drug Administration (FDA) is classifying the prostate lesion documentation system 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 prostate lesion documentation system 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.
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