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| HHS/FDA | RIN: 0910-AC30 | Publication ID: Spring 2007 |
| 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 standard identified in the special controls guidance document 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; 21 CFR 868.5905; 21 CFR 5910 | |
| Legal Authority: 21 USC 351; 21 USC 360; 21 USC 360(c); 21 USC 360e; 21 USC 360j; 21 USC 371 | |
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Legal Deadline:
None |
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Timetable:
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| Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: Undetermined |
| Federalism: Undetermined | |
| Included in the Regulatory Plan: No | |
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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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