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withdrawn,object_id FDA-2017-N-1129-0058,FDA,FDA-2017-N-1129,"Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff",Other,Guidance,2020-05-04T04:00:00Z,2020,5,2020-05-04T04:00:00Z,,2024-11-06T23:35:53Z,,1,0,090000648452df2a FDA-2017-N-1129-0057,FDA,FDA-2017-N-1129,"Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices",Rule,Final Rule,2019-12-30T05:00:00Z,2019,12,2019-12-30T05:00:00Z,,2019-12-30T16:00:40Z,2019-27394,0,0,090000648425877b FDA-2017-N-1129-0056,FDA,FDA-2017-N-1129,Medical Devices; Exemptions From Premarket Notification: Class II Devices,Rule,Final Rule,2018-06-05T04:00:00Z,2018,6,2018-06-05T04:00:00Z,,2018-06-05T13:31:25Z,2018-11879,0,0,090000648333c407 FDA-2017-N-1129-0054,FDA,FDA-2017-N-1129,"Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments",Notice,Request for Comments,2017-11-07T05:00:00Z,2017,11,2017-11-07T05:00:00Z,2018-01-09T04:59:59Z,2018-01-09T02:02:27Z,2017-24163,0,0,0900006482c53f22 FDA-2017-N-1129-0053,FDA,FDA-2017-N-1129,Medical Devices: Exemptions from Premarket Notification; Class II Devices,Notice,Announcement,2017-07-11T04:00:00Z,2017,7,2017-07-11T04:00:00Z,,2017-07-11T13:55:40Z,2017-14453,0,0,0900006482908cce FDA-2017-N-1129-0048,FDA,FDA-2017-N-1129,"Attachment 2 Beger et al Metabolomics enables precision medicine: ""A White Paper, Community Perspective"" Metabolomics (20 16) I 2:149 re: Comment from Bruker",Supporting & Related Material,Background Material,2017-05-16T04:00:00Z,2017,5,,,2017-05-16T18:35:46Z,,0,0,09000064825c9a37 FDA-2017-N-1129-0051,FDA,FDA-2017-N-1129,"Attachment 9 Becker, E. High Resolution NMR (Third Edition) Theory and Chemical Applications Table of Contents re: Comment from Bruker",Supporting & Related Material,Background Material,2017-05-16T04:00:00Z,2017,5,,,2017-05-16T19:16:07Z,,0,0,09000064825c9a3d FDA-2017-N-1129-0047,FDA,FDA-2017-N-1129,Attachment 1 Improvement of Biological Product Quality by Application of New Technologies to Characterize of Vaccines and Blood Products: NMR Spectroscopy and Light Scattering re: Comment from Bruker,Supporting & Related Material,Background Material,2017-05-16T04:00:00Z,2017,5,,,2017-05-16T18:29:25Z,,0,0,09000064825c9a36 FDA-2017-N-1129-0049,FDA,FDA-2017-N-1129,Attachment 7 History of Bruker re: Comment from Bruker,Supporting & Related Material,Background Material,2017-05-16T04:00:00Z,2017,5,,,2017-05-16T19:08:41Z,,0,0,09000064825c9a3b FDA-2017-N-1129-0050,FDA,FDA-2017-N-1129,"Attachment 8 Becker, E. A Brief History of Nuclear Magnetic Resonance Anal Chemistry, 65, 6, (1993) re: Comment from Bruker",Supporting & Related Material,Background Material,2017-05-16T04:00:00Z,2017,5,,,2017-05-16T19:12:10Z,,0,0,09000064825c9a3c FDA-2017-N-1129-0001,FDA,FDA-2017-N-1129,Medical Devices: Exemptions From Premarket Notification; Class II Devices; Request for Comments,Notice,Request for Comments,2017-03-14T04:00:00Z,2017,3,2017-03-14T04:00:00Z,2017-05-16T03:59:59Z,2017-05-19T01:00:33Z,2017-04938,0,0,0900006482505fe7 FDA-2017-N-1129-0002,FDA,FDA-2017-N-1129,"Reference 1 - Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff re: Medical Devices: Exemptions From Premarket Notification; Class II Devices; Request for Comments",Supporting & Related Material,Background Material,2017-03-14T04:00:00Z,2017,3,,,2024-11-07T00:55:24Z,,0,0,090000648250645f