{"abstract":"The Food and Drug Administration (FDA) is publishing a proposed rule to reclassify pressure regulators for use with medical oxygen, currently class I devices included in the generic type of device called pressure regulator, into class II, subject to special controls in the form of a guidance document. Pressure regulators for use with all other medical gases will remain in class I, subject only to general controls. FDA is also proposing to establish a separate classification regulation for oxygen conserving devices (or oxygen conservers), now included in the generic type of device called noncontinuous ventilator. Oxygen conserving devices will continue to be classified in class II, but those that incorporate a built-in oxygen pressure regulator will become subject to the special controls guidance if the rule is finalized. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a class II special controls draft guidance for industry and FDA staff entitled \"Class II Special Controls Guidance Document: Oxygen Pressure Regulators and Oxygen Conserving Devices.\" The agency is proposing this action because it believes that special controls are necessary to provide a reasonable assurance of safety and effectiveness for these devices.","action":"Proposed rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2007/02/27/E7-3253.html","cfr_references":[{"chapter":null,"citation_url":null,"part":868,"title":21}],"citation":"72 FR 8643","comment_url":null,"comments_close_on":"2007-05-29","correction_of":null,"corrections":[],"dates":"Submit comments by May 29, 2007. FDA is proposing that any final rule based on this proposed rule be effective 2 years after the date of its publication in the Federal Register.","disposition_notes":null,"docket_ids":["Docket No. 2007N-0019"],"dockets":[],"document_number":"E7-3253","effective_on":null,"end_page":8652,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2007/02/27/E7-3253.xml","html_url":"https://www.federalregister.gov/documents/2007/02/27/E7-3253/medical-devices-anesthesiology-devices-oxygen-pressure-regulators-and-oxygen-conserving-devices","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/E7-3253?publication_date=2007-02-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2007-02-27/E7-3253/mods.xml","not_received_for_publication":null,"page_length":10,"page_views":{"count":927,"last_updated":"2026-04-05 04:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2007-02-27/pdf/E7-3253.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2007-02-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2007/02/27/E7-3253.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-12T21:00:45Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":8643,"subtype":null,"title":"Medical Devices; Anesthesiology Devices; Oxygen Pressure Regulators and Oxygen Conserving Devices","toc_doc":"Oxygen pressure regulators and oxygen conserving devices","toc_subject":"Medical devices:","topics":[],"type":"Proposed Rule","volume":72}