{"abstract":"The Food and Drug Administration (FDA) is reclassifying scented or scented deodorized menstrual pads from class II into class I based on new information respecting such device. FDA is also exempting this device, and one already classified generic type of class I device, unscented menstrual pads, from the requirement of premarket notification, with limitations. FDA has determined that manufacturers' submissions of premarket notifications for these devices are unnecessary for the protection of the public health and that the agency's review of such submissions will not advance its public health mission. These exemptions allow the agency to make better use of its resources and thus better serve the public.","action":"Final 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"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/1996/12/24/96-32550.html","cfr_references":[{"chapter":null,"citation_url":null,"part":884,"title":21}],"citation":"61 FR 67713","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Effective February 24, 1997. Beginning on February 24, 1997, all device manufacturers who have 510(k) submissions pending FDA review for devices falling within a generic category that is subject to this rule, will receive a letter stating that the device is exempt from the premarket notification requirements of the Federal Food, Drug, and Cosmetic Act.","disposition_notes":null,"docket_ids":["Docket No. 95N-0139"],"dockets":[],"document_number":"96-32550","effective_on":"1997-02-24","end_page":67715,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1996/12/24/96-32550/medical-devices-reclassification-and-exemption-from-premarket-notification-for-certain-classified","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/96-32550?publication_date=1996-12-24","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1996-12-24/96-32550/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":75,"last_updated":"2026-07-26 12:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1996-12-24/pdf/96-32550.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1996-12-24","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1996/12/24/96-32550.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-09-21T13:10:09Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":67713,"subtype":null,"title":"Medical Devices; Reclassification and Exemption From Premarket Notification for Certain Classified Devices","toc_doc":null,"toc_subject":null,"topics":[],"type":"Rule","volume":61}