{"abstract":"The Food and Drug Administration (FDA or we) is classifying the absorbable perirectal spacer into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the absorbable perirectal spacer's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.","action":"Final order.","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/2018/01/05/2018-00051.html","cfr_references":[{"chapter":null,"citation_url":null,"part":892,"title":21}],"citation":"83 FR 600","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective January 5, 2018. The classification was applicable on April 1, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2017-N-6539"],"dockets":[],"document_number":"2018-00051","effective_on":"2018-01-05","end_page":602,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/01/05/2018-00051.xml","html_url":"https://www.federalregister.gov/documents/2018/01/05/2018-00051/medical-devices-radiology-devices-classification-of-the-absorbable-perirectal-spacer","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-00051?publication_date=2018-01-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-01-05/2018-00051/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":551,"last_updated":"2026-10-23 18:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-01-05/pdf/2018-00051.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-00051.pdf?1515073546","publication_date":"2018-01-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/01/05/2018-00051.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2017-N-6539","supporting_documents_count":0,"docket_id":"FDA-2017-N-6539","regulation_id_number":null,"title":"Medical Devices; Radiology Devices; Classification of the Absorbable Perirectal Spacer","checked_regulationsdotgov_at":"2018-01-25T06:00:20Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":600,"subtype":null,"title":"Medical Devices; Radiology Devices; Classification of the Absorbable Perirectal Spacer","toc_doc":"Radiology Devices; Classification of the Absorbable Perirectal Spacer","toc_subject":"Medical Devices:","topics":["Medical devices","Radiation protection","X-rays"],"type":"Rule","volume":83}