{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where docket_id = \"FDA-2014-D-1814\" sorted by posted_date descending", "rows": [["FDA-2014-D-1814-0189", "FDA", "FDA-2014-D-1814", "Bacterial Risk Control Strategies for Blood Collection Establishments and\nTransfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Guidance for Industry", "Other", "Guidance", "2020-12-17T05:00:00Z", 2020, 12, "2020-12-17T05:00:00Z", null, "2024-11-12T23:26:59Z", null, 1, 0, "09000064849a65b7"], ["FDA-2014-D-1814-0179", "FDA", "FDA-2014-D-1814", "Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion", "Other", "Guidance", "2019-10-02T04:00:00Z", 2019, 10, "2019-10-02T04:00:00Z", null, "2024-11-12T23:09:28Z", null, 1, 0, "0900006484005149"], ["FDA-2014-D-1814-0178", "FDA", "FDA-2014-D-1814", "Bacterial Risk Control Strategies for Blood Collection Establishments and\nTransfusion Services To Enhance the Safety and Availability of Platelets for Transfusion; Guidance for Industry; Availability", "Notice", "Notice of Data Availability", "2019-10-02T04:00:00Z", 2019, 10, "2019-10-02T04:00:00Z", null, "2019-10-02T13:42:50Z", "2019-21228", 0, 0, "09000064840036e4"], ["FDA-2014-D-1814-0184", "FDA", "FDA-2014-D-1814", "Reference 10 Bacterial Risk final guidance McDonald re: Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion", "Supporting & Related Material", "Background Material", "2019-10-02T04:00:00Z", 2019, 10, null, null, "2019-10-02T16:59:13Z", null, 0, 0, "0900006484005507"], ["FDA-2014-D-1814-0180", "FDA", "FDA-2014-D-1814", "References List  re: Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion", "Supporting & Related Material", "Background Material", "2019-10-02T04:00:00Z", 2019, 10, null, null, "2019-10-02T16:57:42Z", null, 0, 0, "0900006484005501"], ["FDA-2014-D-1814-0182", "FDA", "FDA-2014-D-1814", "Reference 8 Bacterial Risk final guidance  Haass re: Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion", "Supporting & Related Material", "Background Material", "2019-10-02T04:00:00Z", 2019, 10, null, null, "2019-10-02T17:00:16Z", null, 0, 0, "0900006484005505"], ["FDA-2014-D-1814-0181", "FDA", "FDA-2014-D-1814", "Reference 2 Bacterial Risk final guidance  Fatalities Reported to FDA Annual Summary for FY2015 re: Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion", "Supporting & Related Material", "Background Material", "2019-10-02T04:00:00Z", 2019, 10, null, null, "2019-10-02T16:57:59Z", null, 0, 0, "0900006484005aef"], ["FDA-2014-D-1814-0183", "FDA", "FDA-2014-D-1814", "Reference 9 Bacterial Risk final guidance  Brecher re: Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion", "Supporting & Related Material", "Background Material", "2019-10-02T04:00:00Z", 2019, 10, null, null, "2019-10-02T17:00:58Z", null, 0, 0, "0900006484005506"], ["FDA-2014-D-1814-0131", "FDA", "FDA-2014-D-1814", "06 Reference 6 Fatal Sepsis Associated with Bacterial Contamination of Platelets - Utah and California August 2017", "Supporting & Related Material", "Background Material", "2018-12-06T05:00:00Z", 2018, 12, null, null, "2018-12-06T14:51:27Z", null, 0, 0, "090000648394dd60"], ["FDA-2014-D-1814-0130", "FDA", "FDA-2014-D-1814", "05 Reference 5 Bacterial culture reduces but does not eliminate the risk of septic transfusion reactions to single-donor platelets", "Supporting & Related Material", "Background Material", "2018-12-06T05:00:00Z", 2018, 12, null, null, "2018-12-06T14:50:31Z", null, 0, 0, "090000648394da84"], ["FDA-2014-D-1814-0126", "FDA", "FDA-2014-D-1814", "Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion Draft Guidance for Industry", "Other", "Guidance", "2018-12-06T05:00:00Z", 2018, 12, "2018-12-06T05:00:00Z", "2019-02-05T04:59:59Z", "2020-02-07T18:39:47Z", null, 0, 0, "090000648394da7f"], ["FDA-2014-D-1814-0129", "FDA", "FDA-2014-D-1814", "04 Reference 4 Transfusion-related sepsis a silent epidemic", "Supporting & Related Material", "Background Material", "2018-12-06T05:00:00Z", 2018, 12, null, null, "2018-12-06T14:49:40Z", null, 0, 0, "090000648394da83"], ["FDA-2014-D-1814-0134", "FDA", "FDA-2014-D-1814", "09 Reference 9 BPAC-Transcript-071818", "Supporting & Related Material", "Background Material", "2018-12-06T05:00:00Z", 2018, 12, null, null, "2018-12-06T14:53:56Z", null, 0, 0, "090000648394dd63"], ["FDA-2014-D-1814-0128", "FDA", "FDA-2014-D-1814", "03 Reference 3 Detection of septic transfusion reactions to platelet transfusions by active and passive surveillance", "Supporting & Related Material", "Background Material", "2018-12-06T05:00:00Z", 2018, 12, null, null, "2018-12-06T14:48:52Z", null, 0, 0, "090000648394da82"], ["FDA-2014-D-1814-0125", "FDA", "FDA-2014-D-1814", "Bacterial Risk Control Strategies for Blood Collection Establishments and\nTransfusion Services To Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Notice", "Notice of Availability", "2018-12-06T05:00:00Z", 2018, 12, "2018-12-06T05:00:00Z", "2019-02-05T04:59:59Z", "2019-02-05T02:02:20Z", "2018-26477", 0, 0, "090000648394cd15"], ["FDA-2014-D-1814-0132", "FDA", "FDA-2014-D-1814", "07 Reference 7 Apheresis technology correlates with bacterial contamination of platelets and reported septic transfusion reactions", "Supporting & Related Material", "Background Material", "2018-12-06T05:00:00Z", 2018, 12, null, null, "2018-12-06T14:52:14Z", null, 0, 0, "090000648394dd61"], ["FDA-2014-D-1814-0127", "FDA", "FDA-2014-D-1814", "01 Reference 1 Detection of bacterial contamination in prestorage culture-negative apheresis platelets on day of issue with the Pan Genera Detection test", "Supporting & Related Material", "Background Material", "2018-12-06T05:00:00Z", 2018, 12, null, null, "2018-12-06T14:47:53Z", null, 0, 0, "090000648394da81"], ["FDA-2014-D-1814-0133", "FDA", "FDA-2014-D-1814", "08 Reference 8 Transcripts Day 2 BPAC-9-21-12", "Supporting & Related Material", "Background Material", "2018-12-06T05:00:00Z", 2018, 12, null, null, "2018-12-06T14:53:13Z", null, 0, 0, "090000648394dd62"], ["FDA-2014-D-1814-0124", "FDA", "FDA-2014-D-1814", "Supplemental Comment from Verax Biomedical Incorporated", "Other", "Supplemental Comment", "2017-08-16T04:00:00Z", 2017, 8, "2017-08-16T04:00:00Z", null, "2017-08-16T13:56:18Z", null, 0, 0, "0900006482a3613c"], ["FDA-2014-D-1814-0119", "FDA", "FDA-2014-D-1814", "Supplemental Comment from AABB", "Other", "Supplemental Comment", "2017-04-12T04:00:00Z", 2017, 4, "2017-04-12T04:00:00Z", null, "2017-04-12T19:03:48Z", null, 0, 0, "090000648254ecb9"], ["FDA-2014-D-1814-0118", "FDA", "FDA-2014-D-1814", "Supplemental Comment from New York Blood Center (NYBC)", "Other", "Supplemental Comment", "2017-04-06T04:00:00Z", 2017, 4, "2017-04-06T04:00:00Z", null, "2017-04-06T19:54:06Z", null, 0, 0, "090000648254032d"], ["FDA-2014-D-1814-0103", "FDA", "FDA-2014-D-1814", "Attachment 1 FDA Draft Guidance: Apheresis and Pre-Storage Pooled Platelets re: Comment from New York Blood Center (NYBC)", "Supporting & Related Material", "Background Material", "2016-06-14T04:00:00Z", 2016, 6, null, null, "2016-06-14T18:51:36Z", null, 0, 0, "0900006482039d81"], ["FDA-2014-D-1814-0107", "FDA", "FDA-2014-D-1814", "Appendix 1 STRS with Large Volume/Delayed Testing re:  Comment from bioMerieux", "Supporting & Related Material", "Background Material", "2016-06-14T04:00:00Z", 2016, 6, null, null, "2016-06-14T18:59:01Z", null, 0, 0, "0900006482033fc1"], ["FDA-2014-D-1814-0109", "FDA", "FDA-2014-D-1814", "Appendix 3 Equivalence of Pall eBDS (4ml) and BacT/ALERT (8ml) re:  Comment from bioMerieux", "Supporting & Related Material", "Background Material", "2016-06-14T04:00:00Z", 2016, 6, null, null, "2016-06-14T19:02:37Z", null, 0, 0, "0900006482034001"], ["FDA-2014-D-1814-0108", "FDA", "FDA-2014-D-1814", "Appendix 2 comparing Strategies for Primary Testing re:  Comment from bioMerieux", "Supporting & Related Material", "Background Material", "2016-06-14T04:00:00Z", 2016, 6, null, null, "2016-06-14T19:00:48Z", null, 0, 0, "0900006482033fc2"], ["FDA-2014-D-1814-0101", "FDA", "FDA-2014-D-1814", "Attachment 1: Draft Guidance Bacterial Risk Control Strategies Markup re: Comment from Verax Biomedical (Verax)", "Supporting & Related Material", "Background Material", "2016-06-14T04:00:00Z", 2016, 6, null, null, "2016-06-14T18:44:42Z", null, 0, 0, "0900006482039ace"], ["FDA-2014-D-1814-0098", "FDA", "FDA-2014-D-1814", "Attachment 1 Draft Guidance for Industry Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion re: Comment from Cerus", "Supporting & Related Material", "Background Material", "2016-05-25T04:00:00Z", 2016, 5, null, null, "2016-05-25T16:00:17Z", null, 0, 0, "0900006481fef5f9"], ["FDA-2014-D-1814-0041", "FDA", "FDA-2014-D-1814", "Reference 10 Screening Platelet Concentrates for Bacterial Contamination Low Numbers of Bacteria and Slow Growth in Contaminated Units Mandate an Alternative Approach to Product Safety re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T15:43:26Z", null, 0, 0, "0900006481ec38c5"], ["FDA-2014-D-1814-0084", "FDA", "FDA-2014-D-1814", "Reference 53 INTERCEPT System for Platelets Package Insert 51 re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T18:45:58Z", null, 0, 0, "0900006481ec3ca1"], ["FDA-2014-D-1814-0051", "FDA", "FDA-2014-D-1814", "Reference 20 Bacterial detection in apheresis platelets blood systems experience with a two-bottle and one-bottle culture system re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T16:41:03Z", null, 0, 0, "0900006481ec3c76"], ["FDA-2014-D-1814-0058", "FDA", "FDA-2014-D-1814", "Reference 27 The residual risk of sepsis modeling the effect of concentration on bacterial detection in two-bottle culture systems and an estimation of false-negative culture rates re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T17:09:11Z", null, 0, 0, "0900006481ec3c7d"], ["FDA-2014-D-1814-0087", "FDA", "FDA-2014-D-1814", "Reference 56 Evaluation of the effectiveness of a pathogen inactivation technology against clinically relevant transfusion transmitted bacterial strains re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T18:53:40Z", null, 0, 0, "0900006481ec3ca4"], ["FDA-2014-D-1814-0060", "FDA", "FDA-2014-D-1814", "Reference 29 Bacterial contamination of Platelets, Transfusion Apheresis Science re Bacterial Detection Testing by Blood Collection  Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T17:38:39Z", null, 0, 0, "0900006481ec38d9"], ["FDA-2014-D-1814-0061", "FDA", "FDA-2014-D-1814", "Reference 30 Clostridium perfringens in apheresis platelets an unusual contaminant underscores the importance of clinical vigilance for septic transfusion reactions re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T17:41:54Z", null, 0, 0, "0900006481ec38da"], ["FDA-2014-D-1814-0063", "FDA", "FDA-2014-D-1814", "Reference 32 Propriatary Publication AABB Standard 5.1.5.1 re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T17:48:03Z", null, 0, 0, "0900006481ec38dc"], ["FDA-2014-D-1814-0059", "FDA", "FDA-2014-D-1814", "Reference 28 Blood Products Advisory Committee September 21 2012 re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T17:22:08Z", null, 0, 0, "0900006481ec3c7e"], ["FDA-2014-D-1814-0065", "FDA", "FDA-2014-D-1814", "Reference 34 Bacterial contamination in platelets incremental improvements drive down but do not eliminate risk re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T17:53:04Z", null, 0, 0, "0900006481ec38de"], ["FDA-2014-D-1814-0071", "FDA", "FDA-2014-D-1814", "Reference 40 Assessing the effectiveness of whole blood derived platelets stored as a pool a randomized block noninferiority trial re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T18:15:33Z", null, 0, 0, "0900006481ec38eb"], ["FDA-2014-D-1814-0073", "FDA", "FDA-2014-D-1814", "Reference 42 Evolution of surveillance methods for detection of bacterial contamination of platelets in a university hospital 1991 through 2004 re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T18:20:10Z", null, 0, 0, "0900006481ec38ed"], ["FDA-2014-D-1814-0089", "FDA", "FDA-2014-D-1814", "Reference 58 AABB Symposium on Implementation of Pathogen\u2010Reduced Blood Components re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T18:58:06Z", null, 0, 0, "0900006481ec38f7"], ["FDA-2014-D-1814-0091", "FDA", "FDA-2014-D-1814", "Reference 61 The Safety of the Blood Supply \u2014 Time to Raise the Bar re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T19:05:20Z", null, 0, 0, "0900006481ec38fa"], ["FDA-2014-D-1814-0057", "FDA", "FDA-2014-D-1814", "Reference 26 The International Experience of Bacterial Screen Testing of Platelet Components With an Automated Microbial Detection System: A Need for Consensus Testing and Reporting Guidelines re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T17:04:58Z", null, 0, 0, "0900006481ec3c7c"], ["FDA-2014-D-1814-0054", "FDA", "FDA-2014-D-1814", "Reference 23 PL Acrodose PL System Package Insert re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T16:48:47Z", null, 0, 0, "0900006481ec3c79"], ["FDA-2014-D-1814-0086", "FDA", "FDA-2014-D-1814", "Reference 55 Inactivation of Bacteria in Apheresis Platelets with Pathogen Reduction Performed 24 Hours After Inoculation re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T18:51:46Z", null, 0, 0, "0900006481ec3ca3"], ["FDA-2014-D-1814-0088", "FDA", "FDA-2014-D-1814", "Reference 57 Prevention of transfusion of platelet components contaminated with low levels of bacteria: a comparison of bacteria culture and pathogen inactivation methods re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T18:55:50Z", null, 0, 0, "0900006481ec3ca5"], ["FDA-2014-D-1814-0074", "FDA", "FDA-2014-D-1814", "Reference 43 Two-year experience with aerobic culturing of apheresis and whole blood\u2013derived platelets re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T18:22:02Z", null, 0, 0, "0900006481ec38ee"], ["FDA-2014-D-1814-0075", "FDA", "FDA-2014-D-1814", "Reference 44 The use of a bacteria detection system to evaluate bacterial contamination in PLT concentrates re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T18:23:51Z", null, 0, 0, "0900006481ec38ef"], ["FDA-2014-D-1814-0077", "FDA", "FDA-2014-D-1814", "Reference 46 Single-donor platelets reduce the risk of septic platelet transfusion reactions re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T18:28:40Z", null, 0, 0, "0900006481ec38f1"], ["FDA-2014-D-1814-0079", "FDA", "FDA-2014-D-1814", "Reference 48 The Pan Genera Detection Immunoassay a novel point-of-issue method for detection of bacterial contamination in platelet concentrates re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T18:34:47Z", null, 0, 0, "0900006481ec38f3"], ["FDA-2014-D-1814-0040", "FDA", "FDA-2014-D-1814", "Reference 9 Impact of Increasing Sample Volume from 4 ml to 8 ml on Bacterial Detection Rates in Apheresis Platelets: A Meta Analysis re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T15:39:43Z", null, 0, 0, "0900006481ec38c4"], ["FDA-2014-D-1814-0043", "FDA", "FDA-2014-D-1814", "Reference 12 Predicting Improvement in Detection of Bacteria in Apheresis Platelets by Maintaining Constant Component Sampling Proportion re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T15:54:38Z", null, 0, 0, "0900006481ec38c7"], ["FDA-2014-D-1814-0062", "FDA", "FDA-2014-D-1814", "Reference 31 National Blood Collection and Utilization Survey 2011 re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T17:44:28Z", null, 0, 0, "0900006481ec38db"], ["FDA-2014-D-1814-0072", "FDA", "FDA-2014-D-1814", "Reference 41 Bacterial contamination of whole blood\u2013derived platelets: the introduction of sample diversion and prestorage pooling with\nculture testing in the American Red Cross re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T18:18:07Z", null, 0, 0, "0900006481ec38ec"], ["FDA-2014-D-1814-0076", "FDA", "FDA-2014-D-1814", "Reference 45 Relationship between Bacterial Load, Species Virulence, and Transfusion Reaction with Transfusion of Bacterially Contaminated Platelets re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T18:26:57Z", null, 0, 0, "0900006481ec38f0"], ["FDA-2014-D-1814-0092", "FDA", "FDA-2014-D-1814", "Reference 59 AABB Symposium on Implementation of Pathogen\u2010Reduced Blood Components re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T19:06:11Z", null, 0, 0, "0900006481ec38f8"], ["FDA-2014-D-1814-0044", "FDA", "FDA-2014-D-1814", "Reference 13 Blood Products Advisory Committee September 21 2012 re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T15:56:53Z", null, 0, 0, "0900006481ec38c8"], ["FDA-2014-D-1814-0049", "FDA", "FDA-2014-D-1814", "Reference 18 Culture-based bacterial detection systems for platelets the effect of time prior to sampling and duration of incubation required for detection with aerobic culture re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T16:24:05Z", null, 0, 0, "0900006481ec38cd"], ["FDA-2014-D-1814-0039", "FDA", "FDA-2014-D-1814", "Reference 8 Limiting and Detecting Bacterial Contamination of Apheresis Platelets: Inlet Line Diversion and Increased Culture Volume Improve Component Safety re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T15:29:16Z", null, 0, 0, "0900006481ec38b0"], ["FDA-2014-D-1814-0050", "FDA", "FDA-2014-D-1814", "Reference 19 Experience of the Irish Blood Transfusion Service, Blood Products Advisory Committee re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T16:39:01Z", null, 0, 0, "0900006481ec3c75"], ["FDA-2014-D-1814-0052", "FDA", "FDA-2014-D-1814", "Reference 21 Detection of bacterial contamination in prestorage culture-negative apheresis platelets on day of issue with the Pan Genera Detection test re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T16:43:24Z", null, 0, 0, "0900006481ec3c77"], ["FDA-2014-D-1814-0081", "FDA", "FDA-2014-D-1814", "Reference 50 Inter-laboratory comparison of different rapid methods for the detection of bacterial contamination in platelet concentrates re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T18:39:40Z", null, 0, 0, "0900006481ec3c9d"], ["FDA-2014-D-1814-0047", "FDA", "FDA-2014-D-1814", "Reference 16 Bacterial contamination in stored platelets performance of the Pall eBDS system under routine use conditions re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T16:07:50Z", null, 0, 0, "0900006481ec38cb"], ["FDA-2014-D-1814-0055", "FDA", "FDA-2014-D-1814", "Reference 24 Estimation of the detection sensitivity of automated bacterial culture as a function of apheresis collection volume re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T16:50:46Z", null, 0, 0, "0900006481ec3c7a"], ["FDA-2014-D-1814-0056", "FDA", "FDA-2014-D-1814", "Reference 25 Limiting and detecting bacterial contamination of apheresis platelets inlet-line diversion and increased culture volume improve component safety re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T16:56:00Z", null, 0, 0, "0900006481ec3c7b"], ["FDA-2014-D-1814-0080", "FDA", "FDA-2014-D-1814", "Reference 49 Performance of the Rapid Pan Genera Detection (PGD) System for the point of issue screening of platelet concentrates for bacterial contamination re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T18:37:25Z", null, 0, 0, "0900006481ec3c9c"], ["FDA-2014-D-1814-0042", "FDA", "FDA-2014-D-1814", "Reference 11 Screening of Platelets for Bacterial Contamination at the Welsh Blood Service re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T15:48:10Z", null, 0, 0, "0900006481ec38c6"], ["FDA-2014-D-1814-0046", "FDA", "FDA-2014-D-1814", "Reference 15 One Million and Counting Bacterial Screening of Platelet Components by NHSBT Is It an Effective Risk Reduction Measure re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T16:02:40Z", null, 0, 0, "0900006481ec38ca"], ["FDA-2014-D-1814-0064", "FDA", "FDA-2014-D-1814", "Reference 33 AABB Bacterial Contamination Task Force, Survey of methods used to detect bacterial contamination of platelets products in the United States in 2011 re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T17:51:00Z", null, 0, 0, "0900006481ec38dd"], ["FDA-2014-D-1814-0067", "FDA", "FDA-2014-D-1814", "Reference 36 Transfusion-Transmitted Klebsiella pneumoniae Fatalities,\n1995 to 2004 re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T17:59:19Z", null, 0, 0, "0900006481ec38e0"], ["FDA-2014-D-1814-0078", "FDA", "FDA-2014-D-1814", "Reference 47 Routine bacterial screening of apheresis platelets on day 4 using a rapid test a 4-year single-center experience re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T18:30:35Z", null, 0, 0, "0900006481ec38f2"], ["FDA-2014-D-1814-0082", "FDA", "FDA-2014-D-1814", "Reference 51 Routine use of a rapid test to detect bacteria at the time of issue for nonleukoreduced, whole blood\u2013derived platelets re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T18:41:54Z", null, 0, 0, "0900006481ec3c9f"], ["FDA-2014-D-1814-0085", "FDA", "FDA-2014-D-1814", "Reference 54 Pathogen inactivation--defining adequate bacterial protection re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T18:48:54Z", null, 0, 0, "0900006481ec3ca2"], ["FDA-2014-D-1814-0045", "FDA", "FDA-2014-D-1814", "Reference 14 The first year of bacterial screening of Platelet components-The English Experience re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T15:59:57Z", null, 0, 0, "0900006481ec38c9"], ["FDA-2014-D-1814-0048", "FDA", "FDA-2014-D-1814", "Reference 17 Detection of bacterial contamination in prestorage culture-negative apheresis platelets re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T16:10:49Z", null, 0, 0, "0900006481ec38cc"], ["FDA-2014-D-1814-0070", "FDA", "FDA-2014-D-1814", "Reference 39 Bacterial culture of apheresis platelets: a mathematical\nmodel of the residual rate of contamination based on unconfirmed positive results re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T18:13:20Z", null, 0, 0, "0900006481ec38ea"], ["FDA-2014-D-1814-0066", "FDA", "FDA-2014-D-1814", "Reference 35 Public Conference \u2013 Secondary Bacterial Screening of Platelet Components re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T17:56:40Z", null, 0, 0, "0900006481ec38df"], ["FDA-2014-D-1814-0068", "FDA", "FDA-2014-D-1814", "Reference 37 Fatalities Reported to FDA Following Blood Collection Transfusion Annual Summary for Fiscal Year 2012 re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T18:04:31Z", null, 0, 0, "0900006481ec38e1"], ["FDA-2014-D-1814-0069", "FDA", "FDA-2014-D-1814", "Reference 38 Modeling of Bacterial Contamination re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T18:10:53Z", null, 0, 0, "0900006481ec38e2"], ["FDA-2014-D-1814-0090", "FDA", "FDA-2014-D-1814", "Reference 60 Haemovigilance annual report 2013 re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T19:02:35Z", null, 0, 0, "0900006481ec38f9"], ["FDA-2014-D-1814-0053", "FDA", "FDA-2014-D-1814", "Reference 22 Blood Products Advisory Committee, September 21 2012 re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T16:46:07Z", null, 0, 0, "0900006481ec3c78"], ["FDA-2014-D-1814-0083", "FDA", "FDA-2014-D-1814", "Reference 52 Transfusion service perspective Blood Products Advisory Committee Meeting September 21 2012 re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-16T04:00:00Z", 2016, 3, null, null, "2016-03-16T18:43:42Z", null, 0, 0, "0900006481ec3ca0"], ["FDA-2014-D-1814-0031", "FDA", "FDA-2014-D-1814", "Reference List re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-15T04:00:00Z", 2016, 3, null, null, "2016-03-15T21:16:09Z", null, 0, 0, "0900006481ec384a"], ["FDA-2014-D-1814-0033", "FDA", "FDA-2014-D-1814", "Reference 2 Transfusion Related Sepsis A Silent Epidemic re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-15T04:00:00Z", 2016, 3, null, null, "2016-03-15T21:21:02Z", null, 0, 0, "0900006481ec38a8"], ["FDA-2014-D-1814-0038", "FDA", "FDA-2014-D-1814", "Reference 7 Bacterial Contamination in Platelets Incremental  Improvements Drive Down but do not Eliminate Risk re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-15T04:00:00Z", 2016, 3, null, null, "2016-03-15T21:47:09Z", null, 0, 0, "0900006481ec38af"], ["FDA-2014-D-1814-0029", "FDA", "FDA-2014-D-1814", "Bacterial Risk Control Strategies for Blood Collection Establishments and\nTransfusion Services To Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Notice", "Notice of Availability", "2016-03-15T04:00:00Z", 2016, 3, "2016-03-15T04:00:00Z", "2016-06-14T03:59:59Z", "2016-06-14T01:00:46Z", "2016-05718", 0, 0, "0900006481ec3a35"], ["FDA-2014-D-1814-0030", "FDA", "FDA-2014-D-1814", "Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion Draft Guidance for Industry", "Other", "Guidance", "2016-03-15T04:00:00Z", 2016, 3, "2016-03-15T04:00:00Z", null, "2020-02-07T18:40:19Z", null, 0, 0, "0900006481ec37c5"], ["FDA-2014-D-1814-0034", "FDA", "FDA-2014-D-1814", "Reference 3 Bacterial Culture Reduces but does not Eliminate the Risk of Septic Transfusion Reactions to Single-Donor Platelets re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-15T04:00:00Z", 2016, 3, null, null, "2016-03-15T21:24:30Z", null, 0, 0, "0900006481ec38a9"], ["FDA-2014-D-1814-0036", "FDA", "FDA-2014-D-1814", "Reference 5 Screening of Single-Donor Apheresis Platelets for Bacterial Contamination: The PASSPORT Study Results re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-15T04:00:00Z", 2016, 3, null, null, "2016-03-15T21:29:30Z", null, 0, 0, "0900006481ec38ab"], ["FDA-2014-D-1814-0032", "FDA", "FDA-2014-D-1814", "Reference 1 Detection of Septic Transfusion Reactions to Platelet Transfusions by Active and Passive Surveillance re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-15T04:00:00Z", 2016, 3, null, null, "2016-03-15T21:19:02Z", null, 0, 0, "0900006481ec38a7"], ["FDA-2014-D-1814-0037", "FDA", "FDA-2014-D-1814", "Reference 6  Improving the Performance of Culture-Based Bacterial Screening by Increasing the Sample Volume from 4 mL to 8 mL in Aerobic Culture Bottles re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-15T04:00:00Z", 2016, 3, null, null, "2016-03-15T21:37:34Z", null, 0, 0, "0900006481ec38ae"], ["FDA-2014-D-1814-0035", "FDA", "FDA-2014-D-1814", "Reference 4 Public Conference \u2013 Secondary Bacterial Screening of Platelet Components re Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability", "Supporting & Related Material", "Background Material", "2016-03-15T04:00:00Z", 2016, 3, null, null, "2016-03-15T21:26:26Z", null, 0, 0, "0900006481ec38aa"], ["FDA-2014-D-1814-0028", "FDA", "FDA-2014-D-1814", "Supplement from Verax Biomedical", "Other", "Supplement (SUP)", "2015-08-25T04:00:00Z", 2015, 8, "2015-08-25T04:00:00Z", null, "2015-08-25T15:33:26Z", null, 0, 0, "0900006481bae96a"], ["FDA-2014-D-1814-0003", "FDA", "FDA-2014-D-1814", "Reference List Bacterial Detection Testing re Draft Guidance for Industry Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion, FDA-2014-D-1814-0002", "Supporting & Related Material", "Background Material", "2015-01-09T05:00:00Z", 2015, 1, null, null, "2015-01-11T16:18:46Z", null, 0, 0, "090000648196fa4c"], ["FDA-2014-D-1814-0005", "FDA", "FDA-2014-D-1814", "Reference  2 Summary AABB Workshop July 2012 re Draft Guidance for Industry Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion, FDA-2014-D-1814-0002", "Supporting & Related Material", "Background Material", "2015-01-09T05:00:00Z", 2015, 1, null, null, "2015-01-11T16:20:28Z", null, 0, 0, "090000648196fa4e"], ["FDA-2014-D-1814-0004", "FDA", "FDA-2014-D-1814", "Reference 1 Fuller et al., Bacterial Culture Reduces but Does not Eliminate the Risk Septic Transfusion Reactions to Single-Donor Platelet re Draft Guidance for Industry Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion, FDA-2014-D-1814-0002", 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