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35 rows where docket_id = "FDA-2025-N-5996" 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-N-5996-0017 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | List of References | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:02:56Z | 0 | 0 | 09000064b92140cd | |||
| FDA-2025-N-5996-0030 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | Reference 13 - Reduction of EpCAM-Positive cells from a cell salvage product is achieved by leucocyte depletion filters alone | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:04:08Z | 0 | 0 | 09000064b9215532 | |||
| FDA-2025-N-5996-0035 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | Reference 17 - Preliminary Regulatory Impact Analysis Initial Regulatory Flexibility Analysis, and Unfunded Mandates Reform Act Analysis: Radiology Devices; Classification of Blood Irradiators | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:04:37Z | 0 | 0 | 09000064b921554c | |||
| FDA-2025-N-5996-0013 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | PRIA Reference 12 - Medical Device User Fee Rates for Fiscal Year 2024 | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:02:34Z | 0 | 0 | 09000064b920ce02 | |||
| FDA-2025-N-5996-0018 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | Reference 1 - Radiological Devices Panel April 12, 2012 Meeting Materials | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:03:00Z | 0 | 0 | 09000064b92140ce | |||
| FDA-2025-N-5996-0023 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | Reference 6 - Serial assessment of biochemical changes in irradiated red blood cells | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:03:34Z | 0 | 0 | 09000064b92140d3 | |||
| FDA-2025-N-5996-0007 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | PRIA Reference 6 - Economic Analysis of CDRH Submission Requirements 2012 | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:01:59Z | 0 | 0 | 09000064b920cdee | |||
| FDA-2025-N-5996-0014 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | PRIA Reference 13 - SBA Table of Small Business Size Standards | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:02:40Z | 0 | 0 | 09000064b920ce03 | |||
| FDA-2025-N-5996-0006 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | PRIA Reference 5 - May 2024 National Industry-Specific Occupational Employment | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:01:53Z | 0 | 0 | 09000064b920cded | |||
| FDA-2025-N-5996-0033 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | Reference 15b - Radiobiology for the Radiologist Chapter 10 - Radiation Carcinogenesis | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:04:24Z | 0 | 0 | 09000064b921554a | |||
| FDA-2025-N-5996-0011 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | PRIA Reference 10 - FDA Reclassification of Medical Device Data System | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:02:23Z | 0 | 0 | 09000064b920ce00 | |||
| FDA-2025-N-5996-0032 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | Reference 15a - Radiobiology for the Radiologist Chapter 2 - Molecular Mechanisms of DNA and Chromosome Damage and Repair | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:04:18Z | 0 | 0 | 09000064b9215545 | |||
| FDA-2025-N-5996-0024 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | Reference 7 - Influence of Irradiation on Leukodepleted Small Unit Red Blood Cell Bags | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:03:39Z | 0 | 0 | 09000064b92140d4 | |||
| FDA-2025-N-5996-0004 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | PRIA Reference 3 - Transfusion-associated graft-versus-host disease - Holland | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:01:43Z | 0 | 0 | 09000064b920cdeb | |||
| FDA-2025-N-5996-0026 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | Reference 9 - Transfusion-associated graft-versus-host disease transfusion-associated hyperkalemia, and potassium filtration: advancing safety and sufficiency of the blood supply | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:03:48Z | 0 | 0 | 09000064b921552a | |||
| FDA-2025-N-5996-0005 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | PRIA Reference 4 - Recommendations Regarding License Amendments and Procedures | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:01:48Z | 0 | 0 | 09000064b920cdec | |||
| FDA-2025-N-5996-0001 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | Medical Devices; Radiology Devices; Classification of Blood Irradiators | Proposed Rule | Notice of Proposed Rulemaking (NPRM) | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T04:00:00Z | 2026-05-19T03:59:59Z | 2026-05-07T09:00:21Z | 2026-05320 | 1 | 0 | 09000064b92216a5 |
| FDA-2025-N-5996-0029 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | Reference 12 - X‐ray irradiation effectively inactivated lymphocytes in transfusion in vivo monitored by the bioluminescence transfusion-associated graft-versus-host disease model | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:04:03Z | 0 | 0 | 09000064b92151ee | |||
| FDA-2025-N-5996-0002 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | PRIA Reference 1 - FDA Radiological Devices Panel April 12, 2012 Transcript | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:01:31Z | 0 | 0 | 09000064b920cde9 | |||
| FDA-2025-N-5996-0010 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | PRIA Reference 9 - RTI International 2014 FDA Labeling Cost Model 2015 | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:02:17Z | 0 | 0 | 09000064b920cdff | |||
| FDA-2025-N-5996-0019 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | Reference 2 - Radiological Devices Panel November 7, 2023 Meeting Materials | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:03:05Z | 0 | 0 | 09000064b92140cf | |||
| FDA-2025-N-5996-0020 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | Reference 3 - Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:03:15Z | 0 | 0 | 09000064b92140d0 | |||
| FDA-2025-N-5996-0021 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | Reference 4 - Organ damage mitigation with the Baskent Sickle Cell Medical Care Development Program | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:03:23Z | 0 | 0 | 09000064b92140d1 | |||
| FDA-2025-N-5996-0025 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | Reference 8 - Amotosalen UVA treatment inactivates T cells more effectively than the recommended gamma dose for prevention of transfusion-associated graft-versus-host disease | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:03:43Z | 0 | 0 | 09000064b92140d5 | |||
| FDA-2025-N-5996-0034 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | Reference 16 - Effect of in vitro x-irradiation on lymphocyte and granulocyte function | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:04:30Z | 0 | 0 | 09000064b921554b | |||
| FDA-2025-N-5996-0008 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | PRIA Reference 7 - FY 2003 and FY 2004 Unit Costs for the Process of Medical Device | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:02:05Z | 0 | 0 | 09000064b920cdef | |||
| FDA-2025-N-5996-0009 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | PRIA Reference 8 - HHS Guidelines for Regulatory Impact Analysis 2016 | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:02:11Z | 0 | 0 | 09000064b920cdf0 | |||
| FDA-2025-N-5996-0015 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | PRIA Reference 14 - Medical Device Classification Product Codes | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:02:45Z | 0 | 0 | 09000064b920ce04 | |||
| FDA-2025-N-5996-0027 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | Reference 10 - Transfusion‐associated graft‐versus‐host disease reexamined: potential for improved prevention using a universally applied intervention | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:03:52Z | 0 | 0 | 09000064b92147da | |||
| FDA-2025-N-5996-0028 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | Reference 11 - Technical Note: Fricke dosimetry for blood irradiators | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:03:58Z | 0 | 0 | 09000064b9215531 | |||
| FDA-2025-N-5996-0003 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | PRIA Reference 2 - FDA Radiological Devices Panel 3 November 2023 Transcript | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:01:36Z | 0 | 0 | 09000064b920cdea | |||
| FDA-2025-N-5996-0012 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | PRIA Reference 11 - Estimated Cost of Developing a Therapeutic Complex Medical Device | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:02:28Z | 0 | 0 | 09000064b920ce01 | |||
| FDA-2025-N-5996-0016 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | PRIA Reference 15 - Requests for Feedback and Meetings for Medical Device Submissions | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:02:51Z | 0 | 0 | 09000064b920ce05 | |||
| FDA-2025-N-5996-0022 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | Reference 5 - The effect of gamma irradiation on platelet redox state during storage | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:03:29Z | 0 | 0 | 09000064b92140d2 | |||
| FDA-2025-N-5996-0031 | FDA | Medical Devices; Radiology Devices; Classification of Blood Irradiators FDA-2025-N-5996 | Reference 14 - Risk Factors Radiation - NCI | Supporting & Related Material | Background Material | 2026-03-18T04:00:00Z | 2026 | 3 | 2026-03-18T20:04:12Z | 0 | 0 | 09000064b9215533 |
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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;