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withdrawn,object_id FDA-2009-D-0386-0016,FDA,FDA-2009-D-0386,"Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses; Guidance for Industry and Food and Drug Administration Staff; Availability",Notice,Notice of Availability,2017-09-15T04:00:00Z,2017,9,2017-09-15T04:00:00Z,,2017-09-15T14:44:44Z,2017-19612,0,0,0900006482b3afbe FDA-2009-D-0386-0017,FDA,FDA-2009-D-0386,Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses; Guidance for Industry and Food and Drug Administration Staff,Other,Guidance,2017-09-15T04:00:00Z,2017,9,2017-09-15T04:00:00Z,,2024-11-07T01:11:07Z,,1,0,0900006482b3c560 FDA-2009-D-0386-0012,FDA,FDA-2009-D-0386,Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses Draft Guidance for Industry and Food and Drug Administration Staff,Other,Guidance,2015-08-14T04:00:00Z,2015,8,2015-08-14T04:00:00Z,,2024-11-12T05:41:28Z,,1,0,0900006481c20f52 FDA-2009-D-0386-0011,FDA,FDA-2009-D-0386,"Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses; Draft Guidance for Industry and Food and Drug Administration Staff: Availability",Notice,Notice of Availability,2015-08-14T04:00:00Z,2015,8,2015-08-14T04:00:00Z,2015-11-13T04:59:59Z,2015-11-07T02:30:53Z,2015-19983,0,0,0900006481c206a6 FDA-2009-D-0386-0010,FDA,FDA-2009-D-0386,"Guidance for Industry and Staff; Establishing Performance Characteristics of In Vitro Diagnostic Devices for the Detection, etc., of Human Papillomaviruses",Other,Guidance,2011-11-28T05:00:00Z,2011,11,2011-11-28T05:00:00Z,,2015-07-29T16:44:57Z,,0,0,0900006480f7483f FDA-2009-D-0386-0009,FDA,FDA-2009-D-0386,"Guidance for Industry and Staff; Availability: Establishing Performance Characteristics of In Vitro Diagnostic Devices for the Detection, etc., of Human Papillomaviruses",Notice,Notice of Availability,2011-11-28T05:00:00Z,2011,11,2011-11-28T05:00:00Z,,2015-07-29T16:44:35Z,2011-30552,0,0,0900006480f743be FDA-2009-D-0386-0005,FDA,FDA-2009-D-0386,"Enclosure - ""Lee, et al., Signature Sequence Validation of Human Papillomavirus"" - [Sin Hang Lee, MD (Milford Hospital) - Comment]",Supporting & Related Material,,2009-11-05T00:00:00Z,2009,11,,,2009-11-06T01:34:42Z,,0,1,0900006480a4f31c FDA-2009-D-0386-0001,FDA,FDA-2009-D-0386,Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses; Availability,Notice,Notice of Availability,2009-09-09T04:00:00Z,2009,9,2009-09-09T04:00:00Z,2009-12-09T04:59:59Z,2015-07-29T16:43:45Z,E9-21725,0,0,0900006480a1f23a FDA-2009-D-0386-0002,FDA,FDA-2009-D-0386,Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses - Draft Guidance,Other,GDL-Guidance (Supporting and Related Materials),2009-09-09T04:00:00Z,2009,9,2009-09-09T04:00:00Z,,2024-11-12T04:40:42Z,,1,0,0900006480a1f52d