title: Medical devices; gastroenterology-urology devices; classification of the rectal control system. Final order.
abstract: The Food and Drug Administration (FDA) is classifying the rectal control 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 rectal control system'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.
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D005242:Fecal Incontinence / Q000517:prevention & control*; D005260:Female; D005762:Gastroenterology / Q000145:classification* / Q000295:instrumentation*; D006801:Humans; D012007:Rectum; D014481:United States