title: Medical Devices; Gastroenterology-Urology Devices; Classification   of the Prostate Lesion Documentation System. Final order.
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.
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D004282:Documentation / Q000145:classification*; D004869:Equipment Safety / Q000145:classification*; D006801:Humans; D008297:Male; D011471:Prostatic Neoplasms; D014481:United States; D014572:Urology / Q000145:classification* / Q000295:instrumentation*