{"abstract":"The Food and Drug Administration (FDA) is proposing to reclassify diagnostic endoscopic light source systems (product code OAY), which are postamendments class III devices, from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name \"Cystoscopic system intended as an aid for detection of bladder cancer,\" along with special controls that FDA believes are necessary to provide a reasonable assurance of the safety and effectiveness of these devices.","action":"Proposed amendment; proposed order; request for comments.","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/2026/08/17/2026-16728.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"876","title":21}],"citation":"91 FR 53209","comment_url":"http://www.regulations.gov/commenton/FDA-2026-N-8249-0001","comments_close_on":"2026-10-16","correction_of":null,"corrections":[],"dates":"Either electronic or written comments on the proposed order must be submitted by October 16, 2026. Please see Section X of this document for the proposed effective date when the new requirements would apply and for the proposed effective date of a final order based on this proposed order.","disposition_notes":null,"docket_ids":["Docket No. FDA-2026-N-8249"],"dockets":[{"supporting_documents":[{"title":"Reference 15 - National Cancer Institute Bladder Cancer - Cancer Stat Facts","document_id":"FDA-2026-N-8249-0017"},{"title":"Reference 14 - Efficacy and safety of hexaminolevulinate fluorescence cystoscopy in the diagnosis of bladder cancer","document_id":"FDA-2026-N-8249-0016"},{"title":"Reference 13 - Improved diagnosis and long-term recurrence rate reduction for non-muscle-invasive","document_id":"FDA-2026-N-8249-0015"},{"title":"Reference 12 - Hexylaminolaevulinate fluorescence cystoscopy in patients previously treated with","document_id":"FDA-2026-N-8249-0014"},{"title":"Reference 11 - Racial differences in detection rate of bladder cancer using blue light cystoscopy","document_id":"FDA-2026-N-8249-0013"},{"title":"Reference 10 - Effectiveness of hexaminolevulinate fluorescence cystoscopy for the diagnosis of","document_id":"FDA-2026-N-8249-0012"},{"title":"Reference 9 - Hexaminolevulinate guided fluorescence cystoscopy reduces recurrence in patients","document_id":"FDA-2026-N-8249-0011"},{"title":"Reference 8 - Efficacy and safety of blue light flexible cystoscopy with hexaminolevulinate","document_id":"FDA-2026-N-8249-0010"},{"title":"Reference 7 - P050027 Summary of Safety and Effectiveness (SSED)","document_id":"FDA-2026-N-8249-0009"},{"title":"Reference 6 - First-Cohort-of-Results-of-the-2014-2015-Strategic-Priority","document_id":"FDA-2026-N-8249-0008"}],"agency_name":"FDA","documents":[{"comment_count":1,"comment_start_date":"2026-08-17","updated_at":"2026-09-07T01:55:42.486-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-N-8249-0001","allow_late_comments":false,"id":"FDA-2026-N-8249-0001","comment_end_date":"2026-10-17","regulations_dot_gov_open_for_comment":true}],"supporting_documents_count":16,"id":"FDA-2026-N-8249","title":"Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended As An Aid For Detection of Bladder Cancer"}],"document_number":"2026-16728","effective_on":null,"end_page":53217,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/08/17/2026-16728.xml","html_url":"https://www.federalregister.gov/documents/2026/08/17/2026-16728/gastroenterology-urology-devices-reclassification-of-diagnostic-endoscopic-light-source-systems-to","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-16728?publication_date=2026-08-17","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-08-17/2026-16728/mods.xml","not_received_for_publication":null,"page_length":9,"page_views":{"count":1516,"last_updated":"2026-09-21 20:15:12 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-17/pdf/2026-16728.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-16728.pdf?1786711515","publication_date":"2026-08-17","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/08/17/2026-16728.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 15 - National Cancer Institute Bladder Cancer - Cancer Stat Facts","document_id":"FDA-2026-N-8249-0017"},{"title":"Reference 14 - Efficacy and safety of hexaminolevulinate fluorescence cystoscopy in the diagnosis of bladder cancer","document_id":"FDA-2026-N-8249-0016"},{"title":"Reference 13 - Improved diagnosis and long-term recurrence rate reduction for non-muscle-invasive","document_id":"FDA-2026-N-8249-0015"},{"title":"Reference 12 - Hexylaminolaevulinate fluorescence cystoscopy in patients previously treated with","document_id":"FDA-2026-N-8249-0014"},{"title":"Reference 11 - Racial differences in detection rate of bladder cancer using blue light cystoscopy","document_id":"FDA-2026-N-8249-0013"},{"title":"Reference 10 - Effectiveness of hexaminolevulinate fluorescence cystoscopy for the diagnosis of","document_id":"FDA-2026-N-8249-0012"},{"title":"Reference 9 - Hexaminolevulinate guided fluorescence cystoscopy reduces recurrence in patients","document_id":"FDA-2026-N-8249-0011"},{"title":"Reference 8 - Efficacy and safety of blue light flexible cystoscopy with hexaminolevulinate","document_id":"FDA-2026-N-8249-0010"},{"title":"Reference 7 - P050027 Summary of Safety and Effectiveness (SSED)","document_id":"FDA-2026-N-8249-0009"},{"title":"Reference 6 - First-Cohort-of-Results-of-the-2014-2015-Strategic-Priority","document_id":"FDA-2026-N-8249-0008"}],"comments_count":1,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2026-N-8249","supporting_documents_count":16,"docket_id":"FDA-2026-N-8249","document_id":"FDA-2026-N-8249-0001","regulation_id_number":null,"title":"Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended As An Aid For Detection of Bladder Cancer","checked_regulationsdotgov_at":"2026-09-08T08:55:04Z"},"regulations_dot_gov_url":"http://www.regulations.gov/commenton/FDA-2026-N-8249-0001","significant":null,"signing_date":null,"start_page":53209,"subtype":null,"title":"Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer","toc_doc":"Reclassification of Diagnostic Endoscopic Light Source Systems to Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer","toc_subject":"Gastroenterology-Urology Devices","topics":["Medical devices"],"type":"Proposed Rule","volume":91}