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HHS/FDA RIN: 0910-AC30 Publication ID: Fall 2006 
Title: Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure Regulators for Use With Medical Oxygen and Separate Classification of Oxygen Conserving Devices 
Abstract: The Food and Drug Administration (FDA) is proposing to reclassify pressure regulators for use with medical oxygen from class I to class II, establish a separate classification for oxygen conserving devices, and establish a special control for these devices to address problems of fire and explosion associated with use of these devices. The special control would be a guidance document that includes standardized testing, performance, and labeling guidance for industry. Devices that meet the special control would be exempt from the premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (the Act). The agency believes it is taking a least burdensome approach for industry. The requirements of the proposed rule would be phased-in to minimize the cost of complying with the special control. FDA seeks to reclassify these devices under section 513(e)(1) of the act (21 U.S.C. 360c(e)(1)). 
Agency: Department of Health and Human Services(HHS)  Priority: Routine and Frequent 
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 868.2750 
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  12/00/2006   
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Federalism: Undetermined 
Included in the Regulatory Plan: No 
Agency Contact:
Nancy Pirt
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-6248
Fax:301 847-8145
Email: nancy.pirt@fda.hhs.gov

 
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