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HHS/FDA RIN: 0910-AC30 Publication ID: Fall 2003 
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    21 CFR 868.5905   
Legal Authority: 21 USC 351    21 USC 352    21 USC 360c(e)(1)    21 USC 371   
Legal Deadline:  None
Action Date FR Cite
NPRM  12/00/2003    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Federalism: Undetermined 
Included in the Regulatory Plan: No 
Agency Contact:
Joseph M. Sheehan
Chief, Regulations Staff
Department of Health and Human Services
Food and Drug Administration
HFZ-215, Center for Devices and Radiological Health, HFZ-215, 1350 Piccard Drive,
Rockville, MD 20850
Phone:301 827-2974
Fax:301 594-4765

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