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withdrawn,object_id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-2016-D-2565-0036,FDA,FDA-2016-D-2565,"510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review; Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations",Other,Guidance,2024-11-21T05:00:00Z,2024,11,2024-11-21T05:00:00Z,,2024-11-21T14:12:37Z,,1,0,090000648682bfa0
FDA-2016-D-2565-0035,FDA,FDA-2016-D-2565,"510(k) Third Party Review Program and Third Party Emergency Use Authorization Review; Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability",Notice,Notice of Availability,2024-11-21T05:00:00Z,2024,11,,,2024-11-21T14:14:28Z,2024-27085,0,0,090000648682c244
FDA-2016-D-2565-0030,FDA,FDA-2016-D-2565,Draft Guidance for Industry and FDA_510(k) Third Party Review Program and Third Party EUA Reivew,Other,Guidance,2023-12-22T05:00:00Z,2023,12,2023-12-22T05:00:00Z,2024-02-21T04:59:59Z,2024-11-21T14:13:13Z,,0,0,090000648634e6c9
FDA-2016-D-2565-0029,FDA,FDA-2016-D-2565,"510(k) Third Party Review Program and Third Party Emergency Use
Authorization (EUA) Review; Draft Guidance for Industry, Food and Drug
Administration Staff, and Third Party Review Organizations; Availability",Notice,Notice of Availability,2023-12-21T05:00:00Z,2023,12,,,2023-12-21T17:23:07Z,2023-28095,0,0,090000648634e286
FDA-2016-D-2565-0028,FDA,FDA-2016-D-2565,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2023-02-14T05:00:00Z,2023,2,2023-02-14T05:00:00Z,,2023-02-14T14:49:38Z,2023-03073,0,0,0900006485693529
FDA-2016-D-2565-0027,FDA,FDA-2016-D-2565,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; 510(k) Third-Party Review Program,Notice,30 Day Proposed Information Collection,2022-10-27T04:00:00Z,2022,10,2022-10-27T04:00:00Z,2022-11-29T04:59:59Z,2022-10-27T14:32:02Z,2022-23377,0,0,09000064854627b2
FDA-2016-D-2565-0022,FDA,FDA-2016-D-2565,Agency Information Collection Activities; Proposed Collection; Comment Request; 510(k) Third-Party Review Program,Notice,60 Day Proposed Information Collection,2022-06-24T04:00:00Z,2022,6,2022-06-24T04:00:00Z,2022-08-24T03:59:59Z,2022-10-06T18:45:23Z,2022-13521,0,0,090000648518c24c
FDA-2016-D-2565-0019,FDA,FDA-2016-D-2565,"The 510(k) Third Party Review Program; Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability",Notice,Notice of Availability,2020-03-12T04:00:00Z,2020,3,2020-03-12T04:00:00Z,,2020-03-12T13:19:53Z,2020-05080,0,0,090000648443d205
FDA-2016-D-2565-0020,FDA,FDA-2016-D-2565,"510(k) Third Party Review Program Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations",Other,Guidance,2020-03-12T04:00:00Z,2020,3,2020-03-12T04:00:00Z,,2024-11-12T23:18:21Z,,1,0,090000648443d91b
FDA-2016-D-2565-0018,FDA,FDA-2016-D-2565,"Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals",Notice,Notice of Approval,2019-12-31T05:00:00Z,2019,12,2019-12-31T05:00:00Z,,2019-12-31T14:56:03Z,2019-28249,0,0,090000648425d8ae
FDA-2016-D-2565-0017,FDA,FDA-2016-D-2565,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; 510(k) Third-Party Review Program,Notice,30 Day Proposed Information Collection,2019-10-15T04:00:00Z,2019,10,2019-10-15T04:00:00Z,2019-11-15T04:59:59Z,2019-10-31T14:53:33Z,2019-22345,0,0,090000648408dee4
FDA-2016-D-2565-0011,FDA,FDA-2016-D-2565,Draft Guidance for Industry-510(k) Third Party Review Program,Other,Guidance,2018-09-14T04:00:00Z,2018,9,2018-09-14T04:00:00Z,2018-12-14T04:59:59Z,2024-11-07T01:38:07Z,,1,0,09000064836ef965
FDA-2016-D-2565-0010,FDA,FDA-2016-D-2565,"510(k) Third-Party Review Program; Draft Guidance for Industry, Food and Drug Administration Staff, and Third-Party Review Organizations;
Availability",Notice,Notice of Availability,2018-09-14T04:00:00Z,2018,9,2018-09-14T04:00:00Z,2018-12-14T04:59:59Z,2018-12-14T02:04:21Z,2018-19992,0,0,09000064836ee543
FDA-2016-D-2565-0001,FDA,FDA-2016-D-2565,"510(k) Third Party Review Program; Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability",Notice,Notice of Availability,2016-09-12T04:00:00Z,2016,9,2016-09-12T04:00:00Z,2016-11-15T04:59:59Z,2016-11-15T02:00:50Z,2016-21876,0,0,09000064821f8301
FDA-2016-D-2565-0002,FDA,FDA-2016-D-2565,"Reference 1 - List of References for Third Party Review Program Draft Guidance re 510(k) Third Party Review Program; Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability",Supporting & Related Material,Background Material,2016-09-12T04:00:00Z,2016,9,,,2016-09-12T13:37:15Z,,0,0,09000064821df168
FDA-2016-D-2565-0005,FDA,FDA-2016-D-2565,Draft Guidance for Industry Food and Drug Administration Staff on 510(k) Third Party Review Program,Other,Guidance,2016-09-12T04:00:00Z,2016,9,2016-09-12T04:00:00Z,,2024-11-07T23:49:36Z,,1,0,09000064821f9e4c
FDA-2016-D-2565-0003,FDA,FDA-2016-D-2565,"Reference 2 - International Medical Device Regulators Forum’s Medical Device Single Audit Program documents re 510(k) Third Party Review Program; Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability",Supporting & Related Material,Background Material,2016-09-12T04:00:00Z,2016,9,,,2016-09-12T13:37:25Z,,0,0,09000064821df16c
FDA-2016-D-2565-0004,FDA,FDA-2016-D-2565,"Reference 3 - FDA Draft Guidance entitled Accreditation and Reaccreditation Process for Firms under the Third Party Review Program Part I_ 2013 re 510(k) Third Party Review Program; Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability",Supporting & Related Material,Background Material,2016-09-12T04:00:00Z,2016,9,,,2016-09-12T13:37:35Z,,0,0,09000064821df16e