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HHS/FDA

RIN: 0910-AC30

Publication ID: Fall 2004

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

Timetable:

Action	Date	FR Cite
NPRM	12/00/2004

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 Email: joseph.sheehan@fda.hhs.gov