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withdrawn,object_id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-2018-N-0628-0031,FDA,FDA-2018-N-0628,eCopy Program for Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff,Other,Guidance,2025-12-03T05:00:00Z,2025,12,2025-12-03T05:00:00Z,,2025-12-04T02:12:16Z,,0,0,09000064b90ad119
FDA-2018-N-0628-0030,FDA,FDA-2018-N-0628,Memorandum of Meeting from Ster-O-Wave LLC,Other,Memorandum,2021-08-12T04:00:00Z,2021,8,2022-01-24T05:00:00Z,,2022-01-24T10:22:41Z,,0,0,0900006484f31faa
FDA-2018-N-0628-0025,FDA,FDA-2018-N-0628,07- Final Rule Reference Full FRIA 508,Supporting & Related Material,Background Material,2019-12-19T05:00:00Z,2019,12,,,2019-12-19T15:00:15Z,,0,0,09000064842367ca
FDA-2018-N-0628-0023,FDA,FDA-2018-N-0628,05 - Final Rule Reference 2 About Electronic Submission Gateway,Supporting & Related Material,Background Material,2019-12-17T05:00:00Z,2019,12,,,2019-12-17T20:10:15Z,,0,0,0900006484221abb
FDA-2018-N-0628-0022,FDA,FDA-2018-N-0628,04 - Final Rule Reference 1 eCopy Final Guidance,Supporting & Related Material,Background Material,2019-12-17T05:00:00Z,2019,12,,,2019-12-17T20:08:16Z,,0,0,0900006484221759
FDA-2018-N-0628-0024,FDA,FDA-2018-N-0628,06 - Final Rule Reference 3 Least Burdensome Provisions,Supporting & Related Material,Background Material,2019-12-17T05:00:00Z,2019,12,,,2019-12-17T20:12:55Z,,0,0,0900006484221abc
FDA-2018-N-0628-0021,FDA,FDA-2018-N-0628,Guidance for eCopy Program for Medical Device Submissions (2019),Other,,2019-12-17T00:00:00Z,2019,12,,,2024-11-12T23:15:02Z,,0,1,090000648421e455
FDA-2018-N-0628-0020,FDA,FDA-2018-N-0628,Medical Device Submissions: Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies To Be Required in Electronic Format,Rule,Final Rule,2019-12-16T05:00:00Z,2019,12,2019-12-16T05:00:00Z,,2019-12-16T16:22:23Z,2019-27047,0,0,090000648421276f
FDA-2018-N-0628-0026,FDA,FDA-2018-N-0628,eCopy Program for Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff,Other,Guidance,2019-12-16T05:00:00Z,2019,12,2019-12-16T05:00:00Z,,2024-11-12T23:14:56Z,,1,0,09000064842407e7
FDA-2018-N-0628-0004,FDA,FDA-2018-N-0628,03 - eCopy Proposed Rule Regulatory Impact Analysis,Supporting & Related Material,Background Material,2018-09-13T04:00:00Z,2018,9,,,2018-09-13T16:17:23Z,,0,0,09000064836e8426
FDA-2018-N-0628-0002,FDA,FDA-2018-N-0628,01 - Reference 1-Guidance for eCopy Program for Medical Device Submissions,Supporting & Related Material,Background Material,2018-09-13T04:00:00Z,2018,9,,,2018-09-13T16:15:36Z,,0,0,09000064836e8424
FDA-2018-N-0628-0003,FDA,FDA-2018-N-0628,02 - Reference 2-Electronic Submissions Gateway,Supporting & Related Material,Background Material,2018-09-13T04:00:00Z,2018,9,,,2018-09-13T16:16:30Z,,0,0,09000064836e8425
FDA-2018-N-0628-0001,FDA,FDA-2018-N-0628,"Medical Device Submissions: Amending Premarket Regulations That
Require Multiple Copies and Specify Paper Copies To Be Allowed in
Electronic Format",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2018-09-13T04:00:00Z,2018,9,2018-09-13T04:00:00Z,2018-12-13T04:59:59Z,2018-12-12T02:03:47Z,2018-19865,0,0,09000064836e65a5