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HHS/FDA RIN: 0910-AC30 Publication ID: Fall 2005 
Title: Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure Regulators for Use With Medical Oxygen 
Abstract: The Food and Drug Administration (FDA) is proposing to reclassify pressure regulators for use with medical oxygen from class I to class II and to establish a special control for oxygen pressure regulators to address problems of fire and explosion associated with use of these devices. The special control will be a guidance document that includes standardized testing, performance, and labeling guidance for industry. Devices that meet the special control will be exempt from the premarket notification requirements of the Act. The agency believes it is taking a least burdensome approach for industry. This proposed rule will phase-in a compliance approach that will minimize the cost. FDA seeks to reclassify these devices under section 513(e)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(e)(1)). 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 868.2700   
Legal Authority: 21 USC 351    21 USC 352    21 USC 360c    21 USC 360i    21 USC 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  12/00/2005    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Federalism: Undetermined 
Included in the Regulatory Plan: No 
Agency Contact:
Madhusoodana Nambiar
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health, WO 66, Room 5518, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-5837
Fax:301 847-8145
Email: madhusoodana.nambiar@fda.hhs.gov