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withdrawn,object_id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-2018-N-0236-0010,FDA,FDA-2018-N-0236,06 - Reference 5 - FDA's guidance Collection of Race and Ethnicity Data in Clinical Trials,Supporting & Related Material,Background Material,2019-02-15T05:00:00Z,2019,2,,,2019-02-15T19:28:59Z,,0,0,090000648390d0be
FDA-2018-N-0236-0014,FDA,FDA-2018-N-0236,"10 - Reference 9 - Patient Preference Information--Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests . . .",Supporting & Related Material,Background Material,2019-02-15T05:00:00Z,2019,2,,,2019-02-15T19:32:11Z,,0,0,090000648390d0c2
FDA-2018-N-0236-0009,FDA,FDA-2018-N-0236,05 - Reference 4 - FDA's Guidance Collection of Race and Ethnicity Data in Clinical Trials,Supporting & Related Material,Background Material,2019-02-15T05:00:00Z,2019,2,,,2019-02-15T19:28:19Z,,0,0,090000648390d0bd
FDA-2018-N-0236-0013,FDA,FDA-2018-N-0236,09 - Reference 8 - FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,Supporting & Related Material,Background Material,2019-02-15T05:00:00Z,2019,2,,,2019-02-26T20:09:39Z,,0,0,090000648390d0c1
FDA-2018-N-0236-0005,FDA,FDA-2018-N-0236,01 - List of References,Supporting & Related Material,Background Material,2019-02-15T05:00:00Z,2019,2,,,2019-02-15T19:25:30Z,,0,0,090000648390cc75
FDA-2018-N-0236-0015,FDA,FDA-2018-N-0236,11 - Reference 10 - Preliminary Analysis of Economic Impacts,Supporting & Related Material,Background Material,2019-02-15T05:00:00Z,2019,2,,,2019-02-26T19:59:25Z,,0,0,090000648390d0c3
FDA-2018-N-0236-0006,FDA,FDA-2018-N-0236,02 - Reference 1 - De Novo Classification Process (Evaluation of Automatic Class III Designation) - Final Guidance,Supporting & Related Material,Background Material,2019-02-15T05:00:00Z,2019,2,,,2019-02-26T19:59:00Z,,0,0,090000648390cc76
FDA-2018-N-0236-0012,FDA,FDA-2018-N-0236,"08 - Reference 7 - Use of International Standard ISO-10993, Biological evaluation of medical devices--Part 1-  Evaluation and testing within a risk management process",Supporting & Related Material,Background Material,2019-02-15T05:00:00Z,2019,2,,,2019-02-15T19:30:25Z,,0,0,090000648390d0c0
FDA-2018-N-0236-0011,FDA,FDA-2018-N-0236,07 - Reference 6 - FDA's guidance Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications,Supporting & Related Material,Background Material,2019-02-15T05:00:00Z,2019,2,,,2019-02-15T19:29:43Z,,0,0,090000648390d0bf
FDA-2018-N-0236-0008,FDA,FDA-2018-N-0236,04 - Reference 3 - FDA's guidance - eCopy Program for Medical Device Submissions,Supporting & Related Material,Background Material,2019-02-15T05:00:00Z,2019,2,,,2019-02-15T19:27:37Z,,0,0,090000648390cc78
FDA-2018-N-0236-0007,FDA,FDA-2018-N-0236,"03 - Reference 2 - FDA's guidance ""Procedures for Class II Device Exemptions from Premarket Notification""",Supporting & Related Material,Background Material,2019-02-15T05:00:00Z,2019,2,,,2019-02-26T19:31:29Z,,0,0,090000648390cc77