View Rule

The FDA is proposing to establish special controls for the following class II reprocessed reusable medical devices, including but not limited to: Bronchoscopes and accessories; Gastroenterology and Urology Endoscopes that have elevator channels, including duodenoscopes, panendoscopes, pancreatoscopes, mini-endoscopes, choledochoscopes, and endoscopic ultrasound systems; Colonoscopes and Enteroscopes; Neurological Endoscopes; Automated Endoscope Reprocessors; Ear Nose and Throat (ENT) Endoscopes and accessories, including esophagoscopes, nasopharyngoscopes, laryngoscopes, and mediastinoscopes; Arthroscopes and accessories; Laparoscopic instruments and accessories; Electrosurgical instruments and accessories; and Robotically-assisted surgical devices. FDA is proposing this action, based on the scientific determination that general controls alone are insufficient to provide reasonable assurance of the safety and effectiveness of these devices, and there is sufficient scientific information to establish special controls for the reprocessing of these reusable devices.