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Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act. Guidance for Industry and Food and Drug Administration Staff. 2023. Available from: https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/cybersecurity-medical-devices-refuse-accept-policy-cyber-devices-and-related-systems-under-section"},{"key":"2253_CR5","unstructured":"U.S. Food and Drug Administration. Electronic Submission Template And Resource (eSTAR) Program. 2022. Available from: https:\/\/www.fda.gov\/medical-devices\/how-study-and-market-your-device\/estar-program"},{"key":"2253_CR6","unstructured":"U.S. Food and Drug Administration. Marketing submission recommendations for a predetermined change control plan for AI\/ML-enabled device software functions. 2023. 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Available from: https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfPMN\/pmn.cfm"}],"container-title":["Journal of Imaging Informatics in Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10278-026-02253-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s10278-026-02253-y","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10278-026-02253-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T15:36:43Z","timestamp":1788881803000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s10278-026-02253-y"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,8]]},"references-count":8,"alternative-id":["2253"],"URL":"https:\/\/doi.org\/10.1007\/s10278-026-02253-y","relation":{},"ISSN":["2948-2933"],"issn-type":[{"value":"2948-2933","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,8]]},"assertion":[{"value":"2 August 2026","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"20 August 2026","order":2,"name":"revised","label":"Revised","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"23 August 2026","order":3,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"8 September 2026","order":4,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Not applicable. This is a retrospective, secondary analysis of publicly available, de-identified FDA regulatory records (510(k) database); no human subjects data, biological material, or patient information were used.","order":1,"name":"Ethics","label":"Ethical Approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":2,"name":"Ethics","label":"Consent to Participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":3,"name":"Ethics","label":"Consent for Publication","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The author declares no competing interests.","order":4,"name":"Ethics","label":"Competing interests","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The author acknowledges the use of AI language models for language refinement, structural organization, quantitative data processing (product-code cross-referencing against FDA\u2019s published AI-Enabled Medical Device List, data re-extraction and reconciliation, difference-in-differences regression, event-study estimation, and Bonferroni-corrected heterogeneity testing), and content synthesis in preparing this manuscript. All AI-assisted content, code, and statistical output were rigorously reviewed, edited, and validated by the author to ensure accuracy, originality, and adherence to the underlying data analysis. Full responsibility for the manuscript\u2019s final content rests with the author.","order":5,"name":"Ethics","label":"Declaration of Artificial Intelligence (AI) Use","group":{"name":"EthicsHeading","label":"Declarations"}}]}}