Regulatory Counsel

0910-AH39 201610 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Ear, Nose, and Throat, Gastroenterology-Urology, General and Plastic Surgery, Neurological, Orthopedic, and Radiology Devices; Reprocessing of Reusable Medical Devices Designation of Special Controls

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.

]]> Other Significant Previously Published in The Unified Agenda Proposed Rule Stage Undetermined No 21 CFR 874.4680 21 CFR 874.4710 21 CFR 874.4720 21 CFR 874.4760 21 CFR 876.1500 21 CFR 878.4400 21 CFR 882.1480 21 CFR 888.1100 21 CFR 892.1570 21 U.S.C. 351 21 U.S.C. 360 21 U.S.C. 360c 21 U.S.C. 360l 21 U.S.C. 371 No NPRM 02/00/2017 No No Undetermined No No No No Erica Payne Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-3999 301 847-8145 erica.payne@fda.hhs.gov Center for Devices and Radiological Health, 10903 New Hampshire Avenue, WO 66, Room 5517, Silver Spring MD 20993