{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance titled \"Robotically-Assisted Surgical Devices--Premarket Submissions.\" This draft guidance provides draft recommendations for premarket submissions for robotically- assisted surgical devices (RASDs). This draft guidance is not final nor is it for implementation at this time.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2026/09/25/2026-19704.html","cfr_references":[],"citation":"91 FR 60967","comment_url":"http://www.regulations.gov/commenton/FDA-2026-N-9505-0001","comments_close_on":"2026-11-24","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by November 24, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2026-N-9505"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-09-25","updated_at":"2026-09-25T10:57:35.770-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-N-9505-0001","allow_late_comments":false,"id":"FDA-2026-N-9505-0001","comment_end_date":"2026-11-25","regulations_dot_gov_open_for_comment":true}],"supporting_documents_count":0,"id":"FDA-2026-N-9505","title":"Robotically-Assisted Surgical Devices – Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability"}],"document_number":"2026-19704","effective_on":null,"end_page":60968,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/09/25/2026-19704.xml","html_url":"https://www.federalregister.gov/documents/2026/09/25/2026-19704/robotically-assisted-surgical-devices-premarket-submissions-draft-guidance-for-industry-and-food-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-19704?publication_date=2026-09-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-09-25/2026-19704/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":433,"last_updated":"2026-09-25 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-25/pdf/2026-19704.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-19704.pdf?1790253920","publication_date":"2026-09-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/09/25/2026-19704.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2026-N-9505","supporting_documents_count":0,"docket_id":"FDA-2026-N-9505","document_id":"FDA-2026-N-9505-0001","regulation_id_number":null,"title":"Robotically-Assisted Surgical Devices – Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","checked_regulationsdotgov_at":"2026-09-26T01:55:03Z"},"regulations_dot_gov_url":"http://www.regulations.gov/commenton/FDA-2026-N-9505-0001","significant":null,"signing_date":null,"start_page":60967,"subtype":null,"title":"Robotically-Assisted Surgical Devices-Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Robotically-Assisted Surgical DevicesPremarket Submissions","toc_subject":"Guidance","topics":[],"type":"Notice","volume":91}