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withdrawn,object_id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-D-6535-0009,FDA,FDA-2017-D-6535,Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research Guidance for Industry,Other,Guidance,2019-03-26T04:00:00Z,2019,3,2019-03-26T04:00:00Z,,2024-11-12T22:57:09Z,,1,0,0900006483b2f6b1
FDA-2017-D-6535-0016,FDA,FDA-2017-D-6535,Reference 7 - Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices; Guidance for Industry and Food and Drug Administration Staff RE: Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research Guidance for Industry,Supporting & Related Material,Background Material,2019-03-26T04:00:00Z,2019,3,,,2019-03-26T15:31:28Z,,0,0,0900006483b2fa0f
FDA-2017-D-6535-0013,FDA,FDA-2017-D-6535,Reference 4 - Federal Register Notice International Harmonization; Policy on Standards RE: Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research Guidance for Industry,Supporting & Related Material,Background Material,2019-03-26T04:00:00Z,2019,3,,,2019-03-26T15:32:08Z,,0,0,0900006483b2f6b6
FDA-2017-D-6535-0008,FDA,FDA-2017-D-6535,Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research; Guidance for Industry; Availability,Notice,Notice of Availability,2019-03-26T04:00:00Z,2019,3,2019-03-26T04:00:00Z,,2019-03-26T14:09:07Z,2019-05760,0,0,0900006483b2e430
FDA-2017-D-6535-0012,FDA,FDA-2017-D-6535,"Reference 3 - FDA Staff Manual Guides, Volume IV - Agency Program Directives, Common Standards, Developmant and Use of Standards, SMG 9100.1 RE: Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research Guidance for Industry",Supporting & Related Material,Background Material,2019-03-26T04:00:00Z,2019,3,,,2019-03-26T15:33:06Z,,0,0,0900006483b2f6b5
FDA-2017-D-6535-0014,FDA,FDA-2017-D-6535,Reference 5 - Guidance for Industry Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage RE: Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research Guidance for Industry,Supporting & Related Material,Background Material,2019-03-26T04:00:00Z,2019,3,,,2019-03-26T15:31:06Z,,0,0,0900006483b2fa0d
FDA-2017-D-6535-0015,FDA,FDA-2017-D-6535,Reference 6 - Providing Regulatory Submissions in Electronic Format - Standardized Study Data; Guidance for Industry RE: Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research Guidance for Industry,Supporting & Related Material,Background Material,2019-03-26T04:00:00Z,2019,3,,,2019-03-26T15:31:16Z,,0,0,0900006483b2fa0e
FDA-2017-D-6535-0011,FDA,FDA-2017-D-6535,Reference 2 - National Technology Tranfer and Advancement Act of 1995 RE: Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research Guidance for Industry,Supporting & Related Material,Background Material,2019-03-26T04:00:00Z,2019,3,,,2019-03-26T15:33:50Z,,0,0,0900006483b2f6b4
FDA-2017-D-6535-0010,FDA,FDA-2017-D-6535,Reference 1 - OMB Circular A-119 Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities re: Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research Guidance for Industry,Supporting & Related Material,Background Material,2019-03-26T04:00:00Z,2019,3,,,2019-03-26T15:27:08Z,,0,0,0900006483b2f6b3
FDA-2017-D-6535-0002,FDA,FDA-2017-D-6535,Draft Guidance for Industry on Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research,Other,Guidance,2017-12-19T05:00:00Z,2017,12,2017-12-19T05:00:00Z,,2024-11-07T01:16:23Z,,1,0,0900006482d3bf1b
FDA-2017-D-6535-0001,FDA,FDA-2017-D-6535,"Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research; Draft Guidance for Industry and Food and Drug Administration 
Staff; Availability",Notice,Notice of Availability,2017-12-19T05:00:00Z,2017,12,2017-12-19T05:00:00Z,2018-03-20T03:59:59Z,2018-03-20T01:03:43Z,2017-27275,0,0,0900006482d3ac76