{"abstract":"The Food and Drug Administration (FDA) is issuing a final order reclassifying optical diagnostic devices for melanoma detection (product code OYD) and electrical impedance spectrometers (product code ONV), both postamendments class III device types, into class II (special controls), subject to premarket notification. FDA is also renaming and codifying these devices under the new classification regulation named \"software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer.\" FDA is also establishing the special controls necessary to provide a reasonable assurance of safety and effectiveness of these devices.","action":"Final amendment; 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/2026/03/25/2026-05772.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"878","title":21}],"citation":"91 FR 14445","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective April 24, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2022-N-0794"],"dockets":[{"supporting_documents":[{"title":"Final Order Reference 4 - Requests for Feedback and Meetings for Medical Device Submissions - The Q-Submission Program Guidance for Industry","document_id":"FDA-2022-N-0794-0025"},{"title":"Final Order Reference 3 - P150046 Approval Order","document_id":"FDA-2022-N-0794-0024"},{"title":"Final Order Reference 2 - P090012 Approval Order","document_id":"FDA-2022-N-0794-0023"},{"title":"Final Order Reference 1 - July 28-29 2022 Meeting of the General and Plastic Surgery Devices Panel Meeting Materials","document_id":"FDA-2022-N-0794-0022"}],"agency_name":"FDA","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2026-03-25T10:59:27.843-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-N-0794-0021","allow_late_comments":false,"id":"FDA-2022-N-0794-0021","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":4,"id":"FDA-2022-N-0794","title":"General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Computer-Aided Devices Which Provide Adjunctive Diagnostic Information About Lesions Suspicious for Melanoma"}],"document_number":"2026-05772","effective_on":"2026-04-24","end_page":14458,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/03/25/2026-05772.xml","html_url":"https://www.federalregister.gov/documents/2026/03/25/2026-05772/general-and-plastic-surgery-devices-reclassification-of-optical-diagnostic-devices-for-melanoma","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-05772?publication_date=2026-03-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-03-25/2026-05772/mods.xml","not_received_for_publication":null,"page_length":14,"page_views":{"count":3351,"last_updated":"2026-05-12 10:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-25/pdf/2026-05772.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-05772.pdf?1774356312","publication_date":"2026-03-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/03/25/2026-05772.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Final Order Reference 4 - Requests for Feedback and Meetings for Medical Device Submissions - The Q-Submission Program Guidance for Industry","document_id":"FDA-2022-N-0794-0025"},{"title":"Final Order Reference 3 - P150046 Approval Order","document_id":"FDA-2022-N-0794-0024"},{"title":"Final Order Reference 2 - P090012 Approval Order","document_id":"FDA-2022-N-0794-0023"},{"title":"Final Order Reference 1 - July 28-29 2022 Meeting of the General and Plastic Surgery Devices Panel Meeting Materials","document_id":"FDA-2022-N-0794-0022"}],"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-2022-N-0794","supporting_documents_count":4,"docket_id":"FDA-2022-N-0794","document_id":"FDA-2022-N-0794-0021","regulation_id_number":null,"title":"General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Computer-Aided Devices Which Provide Adjunctive Diagnostic Information About Lesions Suspicious for Melanoma","checked_regulationsdotgov_at":"2026-03-26T22:55:06Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":14445,"subtype":null,"title":"General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Software-Aided Adjunctive Diagnostic Devices for Use on Skin Lesions by Physicians Trained in the Diagnosis and Management of Skin Cancer","toc_doc":"Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Software-Aided Adjunctive Diagnostic Devices for Use on Skin Lesions by Physicians Trained in the Diagnosis and Management of Skin Cancer","toc_subject":"General and Plastic Surgery Devices","topics":["Medical devices"],"type":"Rule","volume":91}