dockets: FDA-2025-N-5996

Regulatory dockets from Regulations.gov — containers for related documents and comments in a rulemaking proceeding.

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id agency_id title docket_type last_modified object_id rin dkabstract category subtype keywords program short_title effective_date organization attrs_raw attr_source
FDA-2025-N-5996 FDA Medical Devices; Radiology Devices; Classification of Blood Irradiators Rulemaking 2026-04-09T14:39:48Z 0b000064b9075db9 Not Assigned The Food and Drug Administration (FDA or Agency) is proposing to classify blood irradiator devices (product code MOT), unclassified preamendments devices, as follows: blood irradiator devices intended to prevent transfusion-associated graft-versus-host disease into class II (special controls) with premarket notification and blood irradiator devices intended to prevent metastasis into class III (premarket approval) to provide a reasonable assurance of safety and effectiveness of these devices. Elsewhere in this issue of the Federal Register, FDA is issuing a proposed order proposing to require the filing of a premarket approval application for blood irradiator devices intended to prevent metastasis.     ["CDRH", "2016-632", "Notice", "Medical Devices", "Radiology Devices", "Classification of Blood Irradiators", "OPEN"] CDRH Medical Devices; Radiology Devices; Classification of Blood Irradiators     {"displayProperties": [{"name": "generic", "label": "Docket Item Code", "tooltip": "Type of Document That Establishes the Docket"}, {"name": "program", "label": "Center", "tooltip": "The agency specific program associated with the docket (regulatory action); equivalents: Docket Item Code, Location."}, {"name": "field2", "label": "Docket Status", "tooltip": " Used to Identity that a Docket's Status is Open or Closed"}, {"name": "shortTitle", "label": "Short Title", "tooltip": "A combination of letters and or numbers assigned to an agency's regulatory action for purposes of brevity."}], "keywords": ["CDRH", "2016-632", "Notice", "Medical Devices", "Radiology Devices", "Classification of Blood Irradiators", "OPEN"], "modifyDate": "2026-04-09T14:39:48Z", "dkAbstract": "The Food and Drug Administration (FDA or Agency) is proposing to classify blood irradiator devices (product code MOT), unclassified preamendments devices, as follows: blood irradiator devices intended to prevent transfusion-associated graft-versus-host disease into class II (special controls) with premarket notification and blood irradiator devices intended to prevent metastasis into class III (premarket approval) to provide a reasonable assurance of safety and effectiveness of these devices. Elsewhere in this issue of the Federal Register, FDA is issuing a proposed order proposing to require the filing of a premarket approval application for blood irradiator devices intended to prevent metastasis.", "agencyId": "FDA", "program": "CDRH", "shortTitle": "Medical Devices; Radiology Devices; Classification of Blood Irradiators", "subType2": null, "title": "Medical Devices; Radiology Devices; Classification of Blood Irradiators", "generic": "N", "field1": null, "docketType": "Rulemaking", "petitionNbr": null, "rin": "Not Assigned", "organization": null, "legacyId": null, "subType": null, "category": null, "field2": "OPEN", "effectiveDate": null, "objectId": "0b000064b9075db9"} single_get

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