{"abstract":"The Food and Drug Administration (FDA) is classifying the hemorrhoid prevention pressure wedge into class II (special controls). The special controls will apply to the device in order to provide a reasonable assurance of safety and effectiveness of the device. A hemorrhoid prevention pressure wedge provides support to the perianal region during the labor and delivery process.","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"},{"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/2011/04/15/2011-9141.html","cfr_references":[{"chapter":null,"citation_url":null,"part":884,"title":21}],"citation":"76 FR 21237","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective May 16, 2011. The classification was applicable on January 13, 2011.","disposition_notes":null,"docket_ids":["Docket No. FDA-2011-N-0118"],"dockets":[],"document_number":"2011-9141","effective_on":"2011-05-16","end_page":21239,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2011/04/15/2011-9141.xml","html_url":"https://www.federalregister.gov/documents/2011/04/15/2011-9141/medical-devices-obstetrical-and-gynecological-devices-classification-of-the-hemorrhoid-prevention","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2011-9141?publication_date=2011-04-15","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2011-04-15/2011-9141/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":148,"last_updated":"2026-04-05 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2011-04-15/pdf/2011-9141.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2011-04-15","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2011/04/15/2011-9141.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-05-05T08:18:16Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":21237,"subtype":null,"title":"Medical Devices; Obstetrical and Gynecological Devices; Classification of the Hemorrhoid Prevention Pressure Wedge","toc_doc":"Classification of the Hemorrhoid Prevention Pressure Wedge","toc_subject":"Medical Devices; Obstetrical and Gynecological Devices:","topics":["Medical devices"],"type":"Rule","volume":76}