dockets: FDA-2025-P-5560

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-P-5560 FDA Requests that the FDA create an alternative pathway for radiology Computer-Aided Detection and/or Diagnosis (CAD) and Computer-Aided Triage and Notification (CADt) devices, partially exempting these devices from the premarket notification requirements of section 510(k) of the FD&C Act. Nonrulemaking 2026-04-02T14:19:47Z 0b000064b904ccdb   CLOSED     ["CDRH", "Citizen Petition", "Rubrum Advising, LLC", "Requests that the FDA create an alternative", "pathway for radiology Computer-Aided Detection", "and/or Diagnosis (CAD) and", "Computer-Aided Triage and Notification (CADt)", "devices, partially exempting these devices from", "the premarket notification requirements of", "section 510(k) of the FD&C Act", "CLOSED"] CDRH Requests that the FDA create an alternative pathway for radiology Computer-Aided Detection and/or Diagnosis (CAD) and Computer-Aided Triage and Notification (CADt) devices     {"displayProperties": [{"name": "abstract", "label": "General Information", "tooltip": "Describes an agency's specific regulatory action; equivalents: Abstract, Description, Docket Subject, Related To, Summary."}, {"name": "generic", "label": "Docket Item Code", "tooltip": "An agency specific code that identifies the type of document that established the docket (regulatory action)."}, {"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", "Citizen Petition", "Rubrum Advising, LLC", "Requests that the FDA create an alternative", "pathway for radiology Computer-Aided Detection", "and/or Diagnosis (CAD) and", "Computer-Aided Triage and Notification (CADt)", "devices, partially exempting these devices from", "the premarket notification requirements of", "section 510(k) of the FD&C Act", "CLOSED"], "modifyDate": "2026-04-02T14:19:47Z", "dkAbstract": "CLOSED", "agencyId": "FDA", "program": "CDRH", "shortTitle": "Requests that the FDA create an alternative pathway for radiology Computer-Aided Detection and/or Diagnosis (CAD) and Computer-Aided Triage and Notification (CADt) devices", "subType2": null, "title": "Requests that the FDA create an alternative pathway for radiology Computer-Aided Detection and/or Diagnosis (CAD) and Computer-Aided Triage and Notification (CADt) devices, partially exempting these devices from the premarket notification requirements of section 510(k) of the FD&C Act.", "generic": "P", "field1": null, "docketType": "Nonrulemaking", "petitionNbr": null, "rin": null, "organization": null, "legacyId": null, "subType": null, "category": null, "field2": "CLOSED", "effectiveDate": null, "objectId": "0b000064b904ccdb"} single_get

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