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withdrawn,object_id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-0507-0037,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