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23 rows where docket_id = "FDA-2025-P-5560" sorted by posted_date descending
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| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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;