{"abstract":"The Food and Drug Administration (FDA) is proposing to reclassify digital breast tomosynthesis (DBT) systems, product code OTE, 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 \"Digital Breast Tomosynthesis System,\" to identify these devices 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/2026/08/10/2026-16209.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"892","title":21}],"citation":"91 FR 51406","comment_url":null,"comments_close_on":"2026-10-09","correction_of":null,"corrections":[],"dates":"Either electronic or written comments on the proposed order must be submitted by October 9, 2026. Please see section X of this document for the proposed effective date when the new requirements 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-7630"],"dockets":[{"supporting_documents":[{"title":"Reference 24 - FDA, “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions--Guidance for Industry and Food and Drug Administration Staff, 2023. Available at: https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/assessing-credibility-computational-modeling-and-simulation-medical-devicesubmissions.","document_id":"FDA-2026-N-7630-0026"},{"title":"Reference 23 - Marshall, N.W., and H. Bosmans. “Performance Evaluation of Digital Breast Tomosynthesis Systems: Comparison of Current Virtual Clinical Trial Methods,” Physics in Medicine & Biology, 67(22):TR04, 2022, https://doi.org/10.1088/1361-6560/ac9a34.","document_id":"FDA-2026-N-7630-0025"},{"title":"Reference 22 - Barufaldi, B., T.L. Vent, P.R. Bakic, et al. “Computer Simulations of Case Difficulty in Digital Breast Tomosynthesis Using Virtual Clinical Trial,” Medical Physics, 49:2220-2232, 2022, https://doi.org/10.1002/mp.15553.","document_id":"FDA-2026-N-7630-0024"},{"title":"Reference 21 - Kiarashi, N., L.W. Nolte, J.Y. Lo, et al. “Impact of Breast Structure on Lesion Detection in Breast Tomosynthesis, a Simulation Study,” Journal of Medical Imaging, 3(3):035504, 2016, https://doi.org/10.1117/1.JMI.3.3.035504.","document_id":"FDA-2026-N-7630-0023"},{"title":"Reference 20 - Badano, A., C.G. Graff, A. Badal, et al. “Evaluation of Digital Breast Tomosynthesis as Replacement of Full-Field Digital Mammography Using an In Silico Imaging Trial,” JAMA Network Open, 1(7), 2018, doi:10.1001/jamanetworkopen.2018.5474, https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2717000.","document_id":"FDA-2026-N-7630-0022"},{"title":"Reference 19 - Cockmartin, L., N.W. Marshall, G. Zhang, et al. “Design and Application of a Structured Phantom for Detection Performance Comparison Between Breast Tomosynthesis and Digital Mammography,” Physics in Medicine & Biology, 62:758-780, 2017, https://doi.org/10.1088/1361-6560/aa5407","document_id":"FDA-2026-N-7630-0021"},{"title":"Reference 18 - Ikejimba, L.C., J. Salad, C.G. Graff, et al. “Assessment of Task-Based Performance from Five Clinical DBT Systems Using an Anthropomorphic Breast Phantom,” Medical Physics, 48(3):1026-1038, 2021, https://doi.org/10.1002/mp.14568.","document_id":"FDA-2026-N-7630-0020"},{"title":"Reference 17 - European Reference Organisation for Quality Assured Breast Screening and Diagnostic Services, “European Guidelines for Quality Assurance in Breast Cancer Screening and Diagnosis,” 2023, https://euref.org/download/european-guidelines-for-quality-assurance-inbreast-cancer-screening-and-diagnosis-pdf-2/.","document_id":"FDA-2026-N-7630-0019"},{"title":"Reference 16 - American College of Radiology, 2018 Digital Mammography Quality Control Manual, Rev. 2nd Ed., May 2020, https://edge.sitecorecloud.io/americancoldf5f-acrorgf92aproductioncb02-3650/media/ACR/Files/Clinical/Quality-Control-Manuals/Mammography-\nQuality-Control-Manual.pdf.","document_id":"FDA-2026-N-7630-0018"},{"title":"Reference 15 - American College of Radiology, “ACR Practice Parameter for the Performance of Screening and Diagnostic (DBT),” 2023, https://gravitas.acr.org/PPTS/GetDocumentView?docId=7","document_id":"FDA-2026-N-7630-0017"}],"agency_name":"FDA","documents":[{"comment_count":8,"comment_start_date":"2026-08-10","updated_at":"2026-10-13T01:55:46.889-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-N-7630-0001","allow_late_comments":false,"id":"FDA-2026-N-7630-0001","comment_end_date":"2026-10-10","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":25,"id":"FDA-2026-N-7630","title":"Radiology Devices; Reclassification of Digital Breast Tomosynthesis System"}],"document_number":"2026-16209","effective_on":null,"end_page":51416,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/08/10/2026-16209.xml","html_url":"https://www.federalregister.gov/documents/2026/08/10/2026-16209/radiology-devices-reclassification-of-digital-breast-tomosynthesis-system","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-16209?publication_date=2026-08-10","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-08-10/2026-16209/mods.xml","not_received_for_publication":null,"page_length":11,"page_views":{"count":2220,"last_updated":"2026-10-25 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-10/pdf/2026-16209.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-16209.pdf?1786106709","publication_date":"2026-08-10","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/08/10/2026-16209.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 24 - FDA, “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions--Guidance for Industry and Food and Drug Administration Staff, 2023. Available at: https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/assessing-credibility-computational-modeling-and-simulation-medical-devicesubmissions.","document_id":"FDA-2026-N-7630-0026"},{"title":"Reference 23 - Marshall, N.W., and H. Bosmans. “Performance Evaluation of Digital Breast Tomosynthesis Systems: Comparison of Current Virtual Clinical Trial Methods,” Physics in Medicine & Biology, 67(22):TR04, 2022, https://doi.org/10.1088/1361-6560/ac9a34.","document_id":"FDA-2026-N-7630-0025"},{"title":"Reference 22 - Barufaldi, B., T.L. Vent, P.R. Bakic, et al. “Computer Simulations of Case Difficulty in Digital Breast Tomosynthesis Using Virtual Clinical Trial,” Medical Physics, 49:2220-2232, 2022, https://doi.org/10.1002/mp.15553.","document_id":"FDA-2026-N-7630-0024"},{"title":"Reference 21 - Kiarashi, N., L.W. Nolte, J.Y. Lo, et al. “Impact of Breast Structure on Lesion Detection in Breast Tomosynthesis, a Simulation Study,” Journal of Medical Imaging, 3(3):035504, 2016, https://doi.org/10.1117/1.JMI.3.3.035504.","document_id":"FDA-2026-N-7630-0023"},{"title":"Reference 20 - Badano, A., C.G. Graff, A. Badal, et al. “Evaluation of Digital Breast Tomosynthesis as Replacement of Full-Field Digital Mammography Using an In Silico Imaging Trial,” JAMA Network Open, 1(7), 2018, doi:10.1001/jamanetworkopen.2018.5474, https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2717000.","document_id":"FDA-2026-N-7630-0022"},{"title":"Reference 19 - Cockmartin, L., N.W. Marshall, G. Zhang, et al. “Design and Application of a Structured Phantom for Detection Performance Comparison Between Breast Tomosynthesis and Digital Mammography,” Physics in Medicine & Biology, 62:758-780, 2017, https://doi.org/10.1088/1361-6560/aa5407","document_id":"FDA-2026-N-7630-0021"},{"title":"Reference 18 - Ikejimba, L.C., J. Salad, C.G. Graff, et al. “Assessment of Task-Based Performance from Five Clinical DBT Systems Using an Anthropomorphic Breast Phantom,” Medical Physics, 48(3):1026-1038, 2021, https://doi.org/10.1002/mp.14568.","document_id":"FDA-2026-N-7630-0020"},{"title":"Reference 17 - European Reference Organisation for Quality Assured Breast Screening and Diagnostic Services, “European Guidelines for Quality Assurance in Breast Cancer Screening and Diagnosis,” 2023, https://euref.org/download/european-guidelines-for-quality-assurance-inbreast-cancer-screening-and-diagnosis-pdf-2/.","document_id":"FDA-2026-N-7630-0019"},{"title":"Reference 16 - American College of Radiology, 2018 Digital Mammography Quality Control Manual, Rev. 2nd Ed., May 2020, https://edge.sitecorecloud.io/americancoldf5f-acrorgf92aproductioncb02-3650/media/ACR/Files/Clinical/Quality-Control-Manuals/Mammography-\nQuality-Control-Manual.pdf.","document_id":"FDA-2026-N-7630-0018"},{"title":"Reference 15 - American College of Radiology, “ACR Practice Parameter for the Performance of Screening and Diagnostic (DBT),” 2023, https://gravitas.acr.org/PPTS/GetDocumentView?docId=7","document_id":"FDA-2026-N-7630-0017"}],"comments_count":8,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2026-N-7630","supporting_documents_count":25,"docket_id":"FDA-2026-N-7630","document_id":"FDA-2026-N-7630-0001","regulation_id_number":null,"title":"Radiology Devices; Reclassification of Digital Breast Tomosynthesis System","checked_regulationsdotgov_at":"2026-10-14T08:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":51406,"subtype":null,"title":"Radiology Devices; Reclassification of Digital Breast Tomosynthesis System","toc_doc":"Reclassification of Digital Breast Tomosynthesis System","toc_subject":"Radiology Devices","topics":["Medical devices","Radiation protection","X-rays"],"type":"Proposed Rule","volume":91}