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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

23 rows where docket_id = "FDA-2025-P-5560" sorted by posted_date descending

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document_type 3

  • Supporting & Related Material 20
  • Other 2
  • Notice 1

posted_year 1

  • 2025 23

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  • FDA 23
id agency_id docket_id title document_type subtype posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-2025-P-5560-0023 FDA None FDA-2025-P-5560 Medical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification Devices Notice Announcement 2025-12-29T05:00:00Z 2025 12 2025-12-29T05:00:00Z 2026-02-28T04:59:59Z 2026-02-28T10:00:12Z 2025-23901 0 0 09000064b910a2ff
FDA-2025-P-5560-0019 FDA None FDA-2025-P-5560 Larson, P. A. (2014). Actionable Findings and the Role of IT Support: Report of the ACR Actionable Reporting Work Group Supporting & Related Material Background Material 2025-10-28T04:00:00Z 2025 10     2025-10-28T23:44:19Z   0 0 09000064b9056f7f
FDA-2025-P-5560-0008 FDA None FDA-2025-P-5560 Asin, S. (2024, December 31). The radiologist shortage, explained Supporting & Related Material Background Material 2025-10-28T04:00:00Z 2025 10     2025-10-28T23:42:56Z   0 0 09000064b90564f9
FDA-2025-P-5560-0014 FDA None FDA-2025-P-5560 Dreyer, K. (2024, November 20). U.S. Food and Drug Administration Supporting & Related Material Background Material 2025-10-28T04:00:00Z 2025 10     2025-10-28T23:43:33Z   0 0 09000064b9056d79
FDA-2025-P-5560-0001 FDA None FDA-2025-P-5560 Citizen Petition from Rubrum Advising, LLC Other Citizen Petition 2025-10-28T04:00:00Z 2025 10 2025-10-28T04:00:00Z   2026-02-20T20:29:49Z   1 0 09000064b904d129
FDA-2025-P-5560-0018 FDA None FDA-2025-P-5560 Jing, A. G. (2025, October 24). AI solutions to the radiology workforce shortage. npj Health Systems, 2(20), 1-6 Supporting & Related Material Background Material 2025-10-28T04:00:00Z 2025 10     2025-10-28T23:44:15Z   0 0 09000064b9056f7e
FDA-2025-P-5560-0012 FDA None FDA-2025-P-5560 Coleman, K. a. (2025, September). Targeted Postmarket Surveillance: The Way Toward Responsible AI Innovation in Health Care Supporting & Related Material Background Material 2025-10-28T04:00:00Z 2025 10     2025-10-28T23:43:22Z   0 0 09000064b9056d77
FDA-2025-P-5560-0006 FDA None FDA-2025-P-5560 American College of Radiology. (n.d.-c.). AI Use Cases: Pneumonia Supporting & Related Material Background Material 2025-10-28T04:00:00Z 2025 10     2025-10-28T23:42:52Z   0 0 09000064b90564f7
FDA-2025-P-5560-0007 FDA None FDA-2025-P-5560 American College of Radiology. (n.d.-d.). Performance Monitoring (Assess-AI) Supporting & Related Material Background Material 2025-10-28T04:00:00Z 2025 10     2025-10-28T23:42:54Z   0 0 09000064b90564f8
FDA-2025-P-5560-0021 FDA None FDA-2025-P-5560 Radboud University Medical Center. (2025). Grand Challenge Supporting & Related Material Background Material 2025-10-28T04:00:00Z 2025 10     2025-10-28T23:44:32Z   0 0 09000064b9056f81
FDA-2025-P-5560-0002 FDA None FDA-2025-P-5560 Acknowledgement Letter from FDA DMB to Rubrum Advising, LLC Other Acknowledgement Letter/Receipt 2025-10-28T04:00:00Z 2025 10 2025-10-28T04:00:00Z   2025-10-28T23:41:18Z   0 0 09000064b904d12a
FDA-2025-P-5560-0004 FDA None FDA-2025-P-5560 American College of Radiology. (n.d.-a.). ACR Recognized Center for Healthcare-AI (ARCH-AI) Supporting & Related Material Background Material 2025-10-28T04:00:00Z 2025 10     2025-10-28T23:42:46Z   0 0 09000064b90564f5
FDA-2025-P-5560-0022 FDA None FDA-2025-P-5560 Salian, I. (2021, March 25). NIH, NVIDIA Use AI to Trace COVID-19 Disease Progression in Chest CT Images Supporting & Related Material Background Material 2025-10-28T04:00:00Z 2025 10     2025-10-28T23:44:35Z   0 0 09000064b9056f82
FDA-2025-P-5560-0003 FDA None FDA-2025-P-5560 Alarcon, N. (2020, February 28). AI Helps Doctors Diagnose the Coronavirus Supporting & Related Material Background Material 2025-10-28T04:00:00Z 2025 10     2025-10-28T23:42:39Z   0 0 09000064b90564ee
FDA-2025-P-5560-0015 FDA None FDA-2025-P-5560 European Commission. (n.d.). EUDAMED - European Database on Medical Devices Supporting & Related Material Background Material 2025-10-28T04:00:00Z 2025 10     2025-10-28T23:43:36Z   0 0 09000064b9056f7a
FDA-2025-P-5560-0009 FDA None FDA-2025-P-5560 Behzad, S., Tabatabaei, S. M., Lu, M. Y., Eibschutz, L. S., & Gholamrezanezhad, A. (2024, July 24). Pitfalls in Interpretive Applications of Artificial Intelligence in Radiology Supporting & Related Material Background Material 2025-10-28T04:00:00Z 2025 10     2025-10-28T23:43:15Z   0 0 09000064b90564fa
FDA-2025-P-5560-0013 FDA None FDA-2025-P-5560 CTA. (2025). Performance Verification and Validation for Predictive Health AI Solutions (CTA-2135) Supporting & Related Material Background Material 2025-10-28T04:00:00Z 2025 10     2025-10-28T23:43:30Z   0 0 09000064b9056d78
FDA-2025-P-5560-0016 FDA None FDA-2025-P-5560 Gonzalez, N. (2025, February 12). New Studies Shed Light on the Future Radiologist Workforce Shortage by Projecting Future Radiologist Supply and Demand for Imaging Supporting & Related Material Background Material 2025-10-28T04:00:00Z 2025 10     2025-10-28T23:43:39Z   0 0 09000064b9056f7b
FDA-2025-P-5560-0017 FDA None FDA-2025-P-5560 Hillis JM, V. J. (2024, Mar 15). The lucent yet opaque challenge of regulating artificial intelligence in radiology Supporting & Related Material Background Material 2025-10-28T04:00:00Z 2025 10     2025-10-28T23:43:50Z   0 0 09000064b9056f7d
FDA-2025-P-5560-0020 FDA None FDA-2025-P-5560 Obuchowski, N. A. (2022, April 1). Multireader Diagnostic Accuracy Imaging Studies: Fundamentals of Design and Analysis. Radiology, 303(1), 26-34 Supporting & Related Material Background Material 2025-10-28T04:00:00Z 2025 10     2025-10-28T23:44:21Z   0 0 09000064b9056f80
FDA-2025-P-5560-0005 FDA None FDA-2025-P-5560 American College of Radiology. (n.d.-b.). AI Central Supporting & Related Material Background Material 2025-10-28T04:00:00Z 2025 10     2025-10-28T23:42:49Z   0 0 09000064b90564f6
FDA-2025-P-5560-0010 FDA None FDA-2025-P-5560 Boon, M. (2025, January 15). Addressing Pathologist Shortages: AI’s Role in Modern Diagnostics Supporting & Related Material Background Material 2025-10-28T04:00:00Z 2025 10     2025-10-28T23:43:17Z   0 0 09000064b9056d75
FDA-2025-P-5560-0011 FDA None FDA-2025-P-5560 Candelon, F. G. (2021, June 4). China’s response to COVID showed the world how to make the most of A.I. Supporting & Related Material Background Material 2025-10-28T04:00:00Z 2025 10     2025-10-28T23:43:20Z   0 0 09000064b9056d76

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;
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