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HHS/FDA RIN: 0910-AH39 Publication ID: Fall 2016 
Title: Ear, Nose, and Throat, Gastroenterology-Urology, General and Plastic Surgery, Neurological, Orthopedic, and Radiology Devices; Reprocessing of Reusable Medical Devices Designation of Special Controls  
Abstract:

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.

 

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: uncollected 
CFR Citation: 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   
Legal Authority: 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   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  02/00/2017 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Undetermined 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Erica Payne
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health, 10903 New Hampshire Avenue, WO 66, Room 5517,
Silver Spring, MD 20993
Phone:301 796-3999
Fax:301 847-8145
Email: erica.payne@fda.hhs.gov