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withdrawn,object_id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-2016-N-2491-0024,FDA,FDA-2016-N-2491,"Withdrawal of the Laser Products; Proposed Amendment to Performance
Standard and the Electronic Submission of Labeling for Certain Home-Use Medical Devices",Proposed Rule,Withdrawal,2018-11-01T04:00:00Z,2018,11,2018-11-01T04:00:00Z,,2018-11-01T14:37:41Z,2018-23916,0,0,090000648387ac10
FDA-2016-N-2491-0003,FDA,FDA-2016-N-2491,Reference 2 - Medical Device Home Use Initiative  re Electronic Submission of Labeling for Certain Home-Use Medical Devices; Proposed Rule,Supporting & Related Material,Background Material,2016-10-18T04:00:00Z,2016,10,,,2016-10-18T14:08:29Z,,0,0,090000648230fb58
FDA-2016-N-2491-0011,FDA,FDA-2016-N-2491,Reference 10 - Medical Device Labeling for Health Care Practitioners Focus Group Study FINAL May 2011 re Electronic Submission of Labeling for Certain Home-Use Medical Devices; Proposed Rule,Supporting & Related Material,Background Material,2016-10-18T04:00:00Z,2016,10,,,2016-10-18T14:17:08Z,,0,0,090000648230fdb3
FDA-2016-N-2491-0012,FDA,FDA-2016-N-2491,Reference 11 - Device Labeling Study- Practitioner Perspectives on Utility Format and Content - Report Summary re Electronic Submission of Labeling for Certain Home-Use Medical Devices; Proposed Rule,Supporting & Related Material,Background Material,2016-10-18T04:00:00Z,2016,10,,,2016-10-18T14:17:37Z,,0,0,090000648230fdc3
FDA-2016-N-2491-0008,FDA,FDA-2016-N-2491,Reference 7 - CDRH Preliminary Internal Evaluations Vol I  510(k) Report re Electronic Submission of Labeling for Certain Home-Use Medical Devices; Proposed Rule,Supporting & Related Material,Background Material,2016-10-18T04:00:00Z,2016,10,,,2016-10-18T14:14:28Z,,0,0,090000648230fdac
FDA-2016-N-2491-0013,FDA,FDA-2016-N-2491,Reference 12 - Public Workshop-Medical Device Labeling September 29-30 2015 re Electronic Submission of Labeling for Certain Home-Use Medical Devices; Proposed Rule,Supporting & Related Material,Background Material,2016-10-18T04:00:00Z,2016,10,,,2016-10-18T14:18:24Z,,0,0,090000648230fdc4
FDA-2016-N-2491-0014,FDA,FDA-2016-N-2491,Reference 13 - PRIA Initial Regulatory Flexibility Analysis and Unfunded Mandates Reform Act Analysis re Electronic Submission of Labeling for Certain Home-Use Medical Devices; Proposed Rule,Supporting & Related Material,Background Material,2016-10-18T04:00:00Z,2016,10,,,2016-10-18T14:19:01Z,,0,0,090000648230fdc5
FDA-2016-N-2491-0005,FDA,FDA-2016-N-2491,Reference 4 - Medical Instrumentation--Accessibility and Usability Considerations -Winters and Story re Electronic Submission of Labeling for Certain Home-Use Medical Devices; Proposed Rule,Supporting & Related Material,Background Material,2016-10-18T04:00:00Z,2016,10,,,2016-10-18T14:10:18Z,,0,0,090000648230fb5a
FDA-2016-N-2491-0002,FDA,FDA-2016-N-2491,Reference 1 -  List of References re Electronic Submission of Labeling for Certain Home-Use Medical Devices; Proposed Rule,Supporting & Related Material,Background Material,2016-10-18T04:00:00Z,2016,10,,,2016-10-18T14:06:01Z,,0,0,0900006482304153
FDA-2016-N-2491-0004,FDA,FDA-2016-N-2491,Reference 3 - Guidance on Medical Device Patient Labeling re Electronic Submission of Labeling for Certain Home-Use Medical Devices; Proposed Rule,Supporting & Related Material,Background Material,2016-10-18T04:00:00Z,2016,10,,,2016-10-18T14:09:09Z,,0,0,090000648230fb59
FDA-2016-N-2491-0007,FDA,FDA-2016-N-2491,Reference 6 - CDRH Preliminary Internal Evaluations Vol II Task Force Report - FINAL re Electronic Submission of Labeling for Certain Home-Use Medical Devices; Proposed Rule,Supporting & Related Material,Background Material,2016-10-18T04:00:00Z,2016,10,,,2016-10-18T14:13:56Z,,0,0,090000648230fdab
FDA-2016-N-2491-0009,FDA,FDA-2016-N-2491,Reference 8 - 510(k) and Science Report Recommendations - Comments Summary re Electronic Submission of Labeling for Certain Home-Use Medical Devices; Proposed Rule,Supporting & Related Material,Background Material,2016-10-18T04:00:00Z,2016,10,,,2016-10-18T14:14:59Z,,0,0,090000648230fdad
FDA-2016-N-2491-0010,FDA,FDA-2016-N-2491,Reference 9 - Transcript of April 7 2011 Public Meeting on Medical Device Use in the Home Environment Workshop re Electronic Submission of Labeling for Certain Home-Use Medical Devices; Proposed Rule,Supporting & Related Material,Background Material,2016-10-18T04:00:00Z,2016,10,,,2016-10-18T14:15:39Z,,0,0,090000648230fdae
FDA-2016-N-2491-0006,FDA,FDA-2016-N-2491,Reference 5 - Basic Statistics About Home Care NAHC 2010 re Electronic Submission of Labeling for Certain Home-Use Medical Devices; Proposed Rule,Supporting & Related Material,Background Material,2016-10-18T04:00:00Z,2016,10,,,2016-10-18T14:10:46Z,,0,0,090000648230fdaa
FDA-2016-N-2491-0001,FDA,FDA-2016-N-2491,Electronic Submission of Labeling for Certain Home-Use Medical Devices,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-10-17T04:00:00Z,2016,10,2016-10-17T04:00:00Z,2017-01-18T04:59:59Z,2017-01-18T02:01:20Z,2016-25026,0,0,0900006482303611