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withdrawn,object_id FDA-2017-N-6730-0041,FDA,FDA-2017-N-6730,Medical Devices and Device-Led Combination Products; Voluntary Malfunction Summary Reporting for Manufacturers,Rule,Final Rule,2024-08-29T04:00:00Z,2024,8,,,2024-08-29T13:19:24Z,2024-19414,0,0,09000064866b35bb FDA-2017-N-6730-0038,FDA,FDA-2017-N-6730,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2021-10-04T04:00:00Z,2021,10,2021-10-04T04:00:00Z,,2021-10-04T22:08:16Z,2021-21386,0,0,0900006484db6ed9 FDA-2017-N-6730-0037,FDA,FDA-2017-N-6730,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Reporting,Notice,30 Day Proposed Information Collection,2021-07-28T04:00:00Z,2021,7,2021-07-28T04:00:00Z,2021-08-28T03:59:59Z,2021-07-28T14:21:18Z,2021-16034,0,0,0900006484c14958 FDA-2017-N-6730-0036,FDA,FDA-2017-N-6730,"Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Reporting",Notice,60 Day Proposed Information Collection,2021-04-29T04:00:00Z,2021,4,2021-04-29T04:00:00Z,2021-06-29T03:59:59Z,2021-05-03T21:35:23Z,2021-08962,0,0,0900006484abc2e8 FDA-2017-N-6730-0035,FDA,FDA-2017-N-6730,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2018-09-28T04:00:00Z,2018,9,2018-09-28T04:00:00Z,,2018-10-23T15:15:20Z,2018-21209,0,0,09000064837801da FDA-2017-N-6730-0034,FDA,FDA-2017-N-6730,Medical Devices and Device-Led Combination Products: Voluntary Malfunction Summary Reporting Program for Manufacturers,Rule,Final Rule,2018-08-17T04:00:00Z,2018,8,2018-08-17T04:00:00Z,,2024-08-29T18:23:06Z,2018-17770,0,0,090000648363074e FDA-2017-N-6730-0033,FDA,FDA-2017-N-6730,"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Malfunction Summary Reporting Program for Manufacturers",Notice,30 Day Proposed Information Collection,2018-06-08T04:00:00Z,2018,6,2018-06-08T04:00:00Z,2018-07-10T03:59:59Z,2018-06-10T01:03:01Z,2018-12336,0,0,0900006483398b52 FDA-2017-N-6730-0007,FDA,FDA-2017-N-6730,"Ref. 1, FDA, Medical Device Reporting--Alternative Summary Reporting (ASR) Program Guidance for Industry",Supporting & Related Material,Background Material,2017-12-26T05:00:00Z,2017,12,,,2017-12-26T17:58:17Z,,0,0,0900006482d737cd FDA-2017-N-6730-0004,FDA,FDA-2017-N-6730,"Ref. 4, MDUFA IV Performance Goals and Procedures. Fiscal Years 2019 through 2022 Commitment Letter",Supporting & Related Material,Background Material,2017-12-26T05:00:00Z,2017,12,,,2017-12-26T17:58:17Z,,0,0,0900006482d737d0 FDA-2017-N-6730-0002,FDA,FDA-2017-N-6730,"Ref. 6, Food and Drug Administration, Electronic Medical Device Reporting",Supporting & Related Material,Background Material,2017-12-26T05:00:00Z,2017,12,,,2017-12-26T17:58:16Z,,0,0,0900006482d73945 FDA-2017-N-6730-0008,FDA,FDA-2017-N-6730,List of References - Voluntary Malfunction Summary Reporting Program fro Manufacturers,Supporting & Related Material,Background Material,2017-12-26T05:00:00Z,2017,12,,,2017-12-26T17:58:17Z,,0,0,0900006482d737cb FDA-2017-N-6730-0005,FDA,FDA-2017-N-6730,"Ref. 3, FDA Form 3500A - MEDWATCH",Supporting & Related Material,Background Material,2017-12-26T05:00:00Z,2017,12,,,2017-12-26T17:58:17Z,,0,0,0900006482d737cf FDA-2017-N-6730-0003,FDA,FDA-2017-N-6730,"Ref. 5, Appedix A, Case Examples of Summary Malfunction Reporting",Supporting & Related Material,Background Material,2017-12-26T05:00:00Z,2017,12,,,2017-12-26T17:58:17Z,,0,0,0900006482d737d1 FDA-2017-N-6730-0006,FDA,FDA-2017-N-6730,"Ref. 2, Food and Drug Administration, MDR Adverse Event Codes",Supporting & Related Material,Background Material,2017-12-26T05:00:00Z,2017,12,,,2017-12-26T17:58:17Z,,0,0,0900006482d737ce FDA-2017-N-6730-0001,FDA,FDA-2017-N-6730,"Center for Devices and Radiological Health; Medical Devices and Combination Products; Voluntary Malfunction Summary Reporting Program for Manufacturers",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2017-12-26T05:00:00Z,2017,12,2017-12-26T05:00:00Z,2018-02-27T04:59:59Z,2024-08-29T18:24:28Z,2017-27650,0,0,0900006482d7293c