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

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35 rows where docket_id = "FDA-2025-N-5996" sorted by posted_date descending

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document_type 2

  • Supporting & Related Material 34
  • Proposed Rule 1

posted_year 1

  • 2026 35

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  • FDA 35
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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;
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