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withdrawn,object_id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-N-0406-0018,FDA,FDA-2016-N-0406,Reference 3 - FDA Executive Summary Blood Products Advisory Committee Meeting - December 3 2014,Supporting & Related Material,Background Material,2018-05-18T04:00:00Z,2018,5,,,2018-05-18T16:37:43Z,,0,0,090000648326b5ce
FDA-2016-N-0406-0015,FDA,FDA-2016-N-0406,Reference 6 - Deciding When to Submit a 510k for a Software Change to an Existing Device Guidance for Industry,Supporting & Related Material,Background Material,2018-05-18T04:00:00Z,2018,5,,,2018-05-18T16:37:40Z,,0,0,090000648326b5d1
FDA-2016-N-0406-0016,FDA,FDA-2016-N-0406,Reference 5 - Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,Supporting & Related Material,Background Material,2018-05-18T04:00:00Z,2018,5,,,2018-05-18T16:37:42Z,,0,0,090000648326b5d0
FDA-2016-N-0406-0020,FDA,FDA-2016-N-0406,Reference 1 - Blood Products Advisory Committee Meeting transcript-March 20 1998,Supporting & Related Material,Background Material,2018-05-18T04:00:00Z,2018,5,,,2018-05-18T16:37:44Z,,0,0,090000648326b5cc
FDA-2016-N-0406-0014,FDA,FDA-2016-N-0406,Medical Devices: Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories,Rule,Final Rule,2018-05-18T04:00:00Z,2018,5,2018-05-18T04:00:00Z,,2018-05-18T14:29:12Z,2018-10610,0,0,090000648327d5df
FDA-2016-N-0406-0019,FDA,FDA-2016-N-0406,Reference 2 - Blood Products Advisory Committee Meeting transcript - December  3 2014,Supporting & Related Material,Background Material,2018-05-18T04:00:00Z,2018,5,,,2018-05-18T16:37:43Z,,0,0,090000648326b5cd
FDA-2016-N-0406-0017,FDA,FDA-2016-N-0406,Reference 4 - General Principles of Software Validation Final Guidance for Industry and FDA Staff,Supporting & Related Material,Background Material,2018-05-18T04:00:00Z,2018,5,,,2018-05-18T16:37:42Z,,0,0,090000648326b5cf
FDA-2016-N-0406-0021,FDA,FDA-2016-N-0406,List of References Final Rule,Supporting & Related Material,Background Material,2018-05-18T04:00:00Z,2018,5,,,2018-05-18T16:37:45Z,,0,0,090000648326b5cb
FDA-2016-N-0406-0005,FDA,FDA-2016-N-0406,Reference 3 - FDA Executive Summary Blood Products Advisory Committee Meeting - December 3 2014 re Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories,Supporting & Related Material,Background Material,2016-03-01T05:00:00Z,2016,3,,,2016-03-03T17:11:00Z,,0,0,0900006481e9506d
FDA-2016-N-0406-0006,FDA,FDA-2016-N-0406,Reference 4 - Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices re Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories,Supporting & Related Material,Background Material,2016-03-01T05:00:00Z,2016,3,,,2016-03-03T17:13:53Z,,0,0,0900006481e9506e
FDA-2016-N-0406-0001,FDA,FDA-2016-N-0406,"Medical Devices; Hematology and Pathology Devices; Classification of
Blood Establishment Computer Software and Accessories",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-03-01T05:00:00Z,2016,3,2016-03-01T05:00:00Z,2016-06-01T03:59:59Z,2016-06-01T01:00:19Z,2016-04411,0,0,0900006481e951c9
FDA-2016-N-0406-0003,FDA,FDA-2016-N-0406,"Reference 1 - Blood Product Advisory Committee Meeting Transcript - March 20, 1998 re Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories",Supporting & Related Material,Background Material,2016-03-01T05:00:00Z,2016,3,,,2016-03-03T17:11:39Z,,0,0,0900006481e9506b
FDA-2016-N-0406-0002,FDA,FDA-2016-N-0406,List of References re Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories,Supporting & Related Material,Background Material,2016-03-01T05:00:00Z,2016,3,,,2016-03-03T17:09:03Z,,0,0,0900006481e95054
FDA-2016-N-0406-0004,FDA,FDA-2016-N-0406,"Reference 2 - Blood Product Advisory Committee Meeting transcript - December  3, 2014 re Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories",Supporting & Related Material,Background Material,2016-03-01T05:00:00Z,2016,3,,,2016-03-03T17:11:21Z,,0,0,0900006481e9506c