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withdrawn,object_id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