{"abstract":"The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance entitled \"Clinical Investigations for Prostate Tissue Ablation Devices.\" This guidance provides recommendations for clinical investigations for high intensity ultrasound systems for prostate tissue ablation and new types of prostatic tissue ablation devices.","action":"Notice of availability.","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/2020/07/15/2020-15263.html","cfr_references":[],"citation":"85 FR 42858","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on July 15, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-D-2223"],"dockets":[],"document_number":"2020-15263","effective_on":null,"end_page":42860,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/07/15/2020-15263.xml","html_url":"https://www.federalregister.gov/documents/2020/07/15/2020-15263/clinical-investigations-for-prostate-tissue-ablation-devices-guidance-for-industry-and-food-and-drug","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-15263?publication_date=2020-07-15","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-07-15/2020-15263/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":160,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-07-15/pdf/2020-15263.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-15263.pdf?1594730739","publication_date":"2020-07-15","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/07/15/2020-15263.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-2019-D-2223","supporting_documents_count":0,"docket_id":"FDA-2019-D-2223","regulation_id_number":null,"title":"Clinical Investigations for Prostate Tissue Ablation Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","checked_regulationsdotgov_at":"2020-07-17T08:30:08Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":42858,"subtype":null,"title":"Clinical Investigations for Prostate Tissue Ablation Devices; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Clinical Investigations for Prostate Tissue Ablation Devices","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":85}