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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Medical Devices; Gastroenterology-Urology Devices; Classification of the Prostate Lesion Documentation System
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 devi...
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80 FR 72899
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“Medical Devices; Gastroenterology-Urology Devices; Classification of the Prostate Lesion Documentation System,” thefederalregister.org (November 23, 2015), https://thefederalregister.org/documents/2015-29632/medical-devices-gastroenterology-urology-devices-classification-of-the-prostate-lesion-documentation-system.