dockets: FDA-2006-P-0149

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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-2006-P-0149 FDA Determine that FDA Would not Regulate as Medical Device Assays Developed by Clinical Laboratories Strictly for In-House use (Home Brew) Nonrulemaking 2022-01-05T01:01:17Z 0b000064804504ed   Docket Status: Closed denied 7/31/2014     ["Administrative Procedure Act (APA)", "laboratory developed tests", "home brew assays", "assays developed by clinical laboratories", "medical devices", "Washing Legal Foundation", "CDRH"] CDRH FDA would not regulate as Medical Device Assays Developed by Clinical Laboratories strictly for in-house use (home brew)     {"displayProperties": [{"name": "abstract", "label": "General Information", "tooltip": "Describes an agency's specific regulatory action; equivalents: Abstract, Description, Docket Subject, Related To, Summary."}, {"name": "legacyId", "label": "Legacy ID", "tooltip": "A pre-FDMS agency specific identifier migrated from a legacy system."}, {"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": ["Administrative Procedure Act (APA)", "laboratory developed tests", "home brew assays", "assays developed by clinical laboratories", "medical devices", "Washing Legal Foundation", "CDRH"], "modifyDate": "2022-01-05T01:01:17Z", "dkAbstract": "Docket Status: Closed denied 7/31/2014", "agencyId": "FDA", "program": "CDRH", "shortTitle": "FDA would not regulate as Medical Device Assays Developed by Clinical Laboratories strictly for in-house use (home brew)", "subType2": null, "title": "Determine that FDA Would not Regulate as Medical Device Assays Developed by Clinical Laboratories Strictly for In-House use (Home Brew)", "generic": "P", "field1": null, "docketType": "Nonrulemaking", "petitionNbr": null, "rin": null, "organization": null, "legacyId": "2006P-0402", "subType": null, "category": null, "field2": "Closed", "effectiveDate": null, "objectId": "0b000064804504ed"} single_get

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