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withdrawn,object_id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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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