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withdrawn,object_id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-2021-N-0507-0089,FDA,FDA-2021-N-0507,Tab A - Final Rule-OMB Original Version,Supporting & Related Material,Background Material,2024-11-04T05:00:00Z,2024,11,,,2024-11-04T20:51:49Z,,0,0,09000064867fbd15
FDA-2021-N-0507-0090,FDA,FDA-2021-N-0507,Tab A - FRIA-OMB Original Version,Supporting & Related Material,Background Material,2024-11-04T05:00:00Z,2024,11,,,2024-11-04T20:51:53Z,,0,0,09000064867fbd16
FDA-2021-N-0507-0088,FDA,FDA-2021-N-0507,Memorandum - E.O. 12866: Medical Devices; Quality System Regulation Amendments (Final Rule),Other,Memorandum,2024-11-04T05:00:00Z,2024,11,2024-11-04T05:00:00Z,,2024-11-04T20:51:41Z,,0,0,09000064867fbc68
FDA-2021-N-0507-0087,FDA,FDA-2021-N-0507,Medical Devices; Quality System Regulation Amendments; Correction,Rule,Correction,2024-10-15T04:00:00Z,2024,10,,,2024-10-15T14:24:08Z,2024-23701,0,0,09000064867ce682
FDA-2021-N-0507-0083,FDA,FDA-2021-N-0507,Medical Devices; Quality System Regulation Amendments,Rule,Final Rule,2024-02-02T05:00:00Z,2024,2,,,2024-02-02T15:49:30Z,2024-01709,0,0,09000064863d7a7f
FDA-2021-N-0507-0085,FDA,FDA-2021-N-0507,"Reference 2 - FDA, ‘‘Regulations Establishing Good Manufacturing Practices for the Manufacture, Packing, Storage, and Installation of Medical Devices.’’ Federal Register, 43: 31508–31532, July 21, 1978.",Supporting & Related Material,Background Material,2024-02-02T05:00:00Z,2024,2,,,2024-02-03T14:07:40Z,,0,0,09000064863d83db
FDA-2021-N-0507-0084,FDA,FDA-2021-N-0507,"Reference 1 - ISO 13485:2016, ‘‘Medical devices - Quality management systems -Requirements for regulatory purposes,’’ 3rd Ed., March 1, 2016.",Supporting & Related Material,Background Material,2024-02-02T05:00:00Z,2024,2,,,2024-02-03T14:07:18Z,,0,0,09000064863d82d7
FDA-2021-N-0507-0086,FDA,FDA-2021-N-0507,"Reference 11 - International Standard, ISO 9000 ‘‘Quality Management Systems - Fundamentals and Vocabulary,’’ ISO 9000:2015; 4th Ed., September 15, 2015. (Available at: ISO 9000:2015(en), Quality management systems -Fundamentals",Supporting & Related Material,Background Material,2024-02-02T05:00:00Z,2024,2,,,2024-02-03T14:07:53Z,,0,0,09000064863d83df
FDA-2021-N-0507-0037,FDA,FDA-2021-N-0507,11 - Reference 10 - ISO 9000-2015,Supporting & Related Material,Background Material,2022-04-19T04:00:00Z,2022,4,,,2022-04-19T18:04:31Z,,0,0,0900006485024712
FDA-2021-N-0507-0030,FDA,FDA-2021-N-0507,06 - Reference 5 - MDSAP-Medical Device Single Audit Program,Supporting & Related Material,Background Material,2022-04-13T04:00:00Z,2022,4,,,2022-04-13T15:00:01Z,,0,0,090000648501543b
FDA-2021-N-0507-0031,FDA,FDA-2021-N-0507,07 - Reference 6 - Global Harmonization Task Force Guidance Document,Supporting & Related Material,Background Material,2022-04-13T04:00:00Z,2022,4,,,2022-04-13T15:01:17Z,,0,0,090000648501543c
FDA-2021-N-0507-0032,FDA,FDA-2021-N-0507,08 - Reference 7 - ISO 14971-2019,Supporting & Related Material,Background Material,2022-04-13T04:00:00Z,2022,4,,,2022-04-13T15:02:24Z,,0,0,090000648501543f
FDA-2021-N-0507-0029,FDA,FDA-2021-N-0507,05 - Reference 4 - ISO 9001-1994,Supporting & Related Material,Background Material,2022-04-13T04:00:00Z,2022,4,,,2022-04-13T14:58:36Z,,0,0,090000648501543e
FDA-2021-N-0507-0025,FDA,FDA-2021-N-0507,01 - List of References,Supporting & Related Material,Background Material,2022-04-13T04:00:00Z,2022,4,,,2022-04-13T14:49:47Z,,0,0,0900006485015438
FDA-2021-N-0507-0027,FDA,FDA-2021-N-0507,03 - Reference 2 - FR-1978-07-21,Supporting & Related Material,Background Material,2022-04-13T04:00:00Z,2022,4,,,2022-04-13T14:56:23Z,,0,0,0900006485015479
FDA-2021-N-0507-0033,FDA,FDA-2021-N-0507,09 - Reference 8 - MDSAP Voluntary Audit Report Pilot 80FR78741,Supporting & Related Material,Background Material,2022-04-13T04:00:00Z,2022,4,,,2022-04-13T15:03:24Z,,0,0,090000648501543d
FDA-2021-N-0507-0026,FDA,FDA-2021-N-0507,02 - Reference 1 - ISO 13485-2016,Supporting & Related Material,Background Material,2022-04-13T04:00:00Z,2022,4,,,2022-04-13T14:51:13Z,,0,0,0900006485015439
FDA-2021-N-0507-0028,FDA,FDA-2021-N-0507,04 - Reference 3 - ISO 13485-1996,Supporting & Related Material,Background Material,2022-04-13T04:00:00Z,2022,4,,,2022-04-13T14:57:28Z,,0,0,090000648501543a
FDA-2021-N-0507-0034,FDA,FDA-2021-N-0507,10 - Reference 9 - International Medical Device Regulators Forum,Supporting & Related Material,Background Material,2022-04-13T04:00:00Z,2022,4,,,2022-04-13T15:04:35Z,,0,0,09000064850154bf
FDA-2021-N-0507-0035,FDA,FDA-2021-N-0507,12 - Reference 11 - Preliminary Regulatory Impact Analysis,Supporting & Related Material,Background Material,2022-04-13T04:00:00Z,2022,4,,,2022-04-13T15:07:32Z,,0,0,09000064850154be
FDA-2021-N-0507-0001,FDA,FDA-2021-N-0507,Medical Devices; Quality System Regulation Amendments,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2022-02-23T05:00:00Z,2022,2,2022-02-23T05:00:00Z,2022-05-25T03:59:59Z,2022-05-27T01:00:45Z,2022-03227,0,0,0900006484f9d925