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withdrawn,object_id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-2014-D-1814-0189,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; Guidance for Industry",Other,Guidance,2020-12-17T05:00:00Z,2020,12,2020-12-17T05:00:00Z,,2024-11-12T23:26:59Z,,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,,2024-11-12T23:09:28Z,,1,0,0900006484005149
FDA-2014-D-1814-0178,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; Guidance for Industry; Availability",Notice,Notice of Data Availability,2019-10-02T04:00:00Z,2019,10,2019-10-02T04:00:00Z,,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,,,2019-10-02T16:59:13Z,,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,,,2019-10-02T16:57:42Z,,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,,,2019-10-02T17:00:16Z,,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,,,2019-10-02T16:57:59Z,,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,,,2019-10-02T17:00:58Z,,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,,,2018-12-06T14:51:27Z,,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,,,2018-12-06T14:50:31Z,,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,,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,,,2018-12-06T14:49:40Z,,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,,,2018-12-06T14:53:56Z,,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,,,2018-12-06T14:48:52Z,,0,0,090000648394da82
FDA-2014-D-1814-0125,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; 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,,,2018-12-06T14:52:14Z,,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,,,2018-12-06T14:47:53Z,,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,,,2018-12-06T14:53:13Z,,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,,2017-08-16T13:56:18Z,,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,,2017-04-12T19:03:48Z,,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,,2017-04-06T19:54:06Z,,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,,,2016-06-14T18:51:36Z,,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,,,2016-06-14T18:59:01Z,,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,,,2016-06-14T19:02:37Z,,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,,,2016-06-14T19:00:48Z,,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,,,2016-06-14T18:44:42Z,,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,,,2016-05-25T16:00:17Z,,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,,,2016-03-16T15:43:26Z,,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,,,2016-03-16T18:45:58Z,,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,,,2016-03-16T16:41:03Z,,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,,,2016-03-16T17:09:11Z,,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,,,2016-03-16T18:53:40Z,,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,,,2016-03-16T17:38:39Z,,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,,,2016-03-16T17:41:54Z,,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,,,2016-03-16T17:48:03Z,,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,,,2016-03-16T17:22:08Z,,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,,,2016-03-16T17:53:04Z,,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,,,2016-03-16T18:15:33Z,,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,,,2016-03-16T18:20:10Z,,0,0,0900006481ec38ed
FDA-2014-D-1814-0089,FDA,FDA-2014-D-1814,Reference 58 AABB Symposium on Implementation of Pathogen‐Reduced 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,,,2016-03-16T18:58:06Z,,0,0,0900006481ec38f7
FDA-2014-D-1814-0091,FDA,FDA-2014-D-1814,Reference 61 The Safety of the Blood Supply — 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,,,2016-03-16T19:05:20Z,,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,,,2016-03-16T17:04:58Z,,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,,,2016-03-16T16:48:47Z,,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,,,2016-03-16T18:51:46Z,,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,,,2016-03-16T18:55:50Z,,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–derived 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,,,2016-03-16T18:22:02Z,,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,,,2016-03-16T18:23:51Z,,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,,,2016-03-16T18:28:40Z,,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,,,2016-03-16T18:34:47Z,,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,,,2016-03-16T15:39:43Z,,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,,,2016-03-16T15:54:38Z,,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,,,2016-03-16T17:44:28Z,,0,0,0900006481ec38db
FDA-2014-D-1814-0072,FDA,FDA-2014-D-1814,"Reference 41 Bacterial contamination of whole blood–derived platelets: the introduction of sample diversion and prestorage pooling with
culture 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,,,2016-03-16T18:18:07Z,,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,,,2016-03-16T18:26:57Z,,0,0,0900006481ec38f0
FDA-2014-D-1814-0092,FDA,FDA-2014-D-1814,Reference 59 AABB Symposium on Implementation of Pathogen‐Reduced 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,,,2016-03-16T19:06:11Z,,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,,,2016-03-16T15:56:53Z,,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,,,2016-03-16T16:24:05Z,,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,,,2016-03-16T15:29:16Z,,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,,,2016-03-16T16:39:01Z,,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,,,2016-03-16T16:43:24Z,,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,,,2016-03-16T18:39:40Z,,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,,,2016-03-16T16:07:50Z,,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,,,2016-03-16T16:50:46Z,,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,,,2016-03-16T16:56:00Z,,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,,,2016-03-16T18:37:25Z,,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,,,2016-03-16T15:48:10Z,,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,,,2016-03-16T16:02:40Z,,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,,,2016-03-16T17:51:00Z,,0,0,0900006481ec38dd
FDA-2014-D-1814-0067,FDA,FDA-2014-D-1814,"Reference 36 Transfusion-Transmitted Klebsiella pneumoniae Fatalities,
1995 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,,,2016-03-16T17:59:19Z,,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,,,2016-03-16T18:30:35Z,,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–derived 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,,,2016-03-16T18:41:54Z,,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,,,2016-03-16T18:48:54Z,,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,,,2016-03-16T15:59:57Z,,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,,,2016-03-16T16:10:49Z,,0,0,0900006481ec38cc
FDA-2014-D-1814-0070,FDA,FDA-2014-D-1814,"Reference 39 Bacterial culture of apheresis platelets: a mathematical
model 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,,,2016-03-16T18:13:20Z,,0,0,0900006481ec38ea
FDA-2014-D-1814-0066,FDA,FDA-2014-D-1814,Reference 35 Public Conference – 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,,,2016-03-16T17:56:40Z,,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,,,2016-03-16T18:04:31Z,,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,,,2016-03-16T18:10:53Z,,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,,,2016-03-16T19:02:35Z,,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,,,2016-03-16T16:46:07Z,,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,,,2016-03-16T18:43:42Z,,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,,,2016-03-15T21:16:09Z,,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,,,2016-03-15T21:21:02Z,,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,,,2016-03-15T21:47:09Z,,0,0,0900006481ec38af
FDA-2014-D-1814-0029,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; 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,,2020-02-07T18:40:19Z,,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,,,2016-03-15T21:24:30Z,,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,,,2016-03-15T21:29:30Z,,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,,,2016-03-15T21:19:02Z,,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,,,2016-03-15T21:37:34Z,,0,0,0900006481ec38ae
FDA-2014-D-1814-0035,FDA,FDA-2014-D-1814,Reference 4 Public Conference – 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,,,2016-03-15T21:26:26Z,,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,,2015-08-25T15:33:26Z,,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,,,2015-01-11T16:18:46Z,,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,,,2015-01-11T16:20:28Z,,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",Supporting & Related Material,Background Material,2015-01-09T05:00:00Z,2015,1,,,2015-01-11T16:19:40Z,,0,0,090000648196fa4d
FDA-2014-D-1814-0006,FDA,FDA-2014-D-1814,"Reference 3 Dumont et al., Screening of Single-Donor Apheresis Platelets for Bacterial Contamination 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,,,2015-01-11T16:21:12Z,,0,0,090000648196fa4f
FDA-2014-D-1814-0002,FDA,FDA-2014-D-1814,Draft Guidance for IndustryBacterial Detection Testing by Blood Collection Establishments and Transfusion Services To Enhance the Safety and Availability of Platelets for Transfusion,Other,Guidance,2014-12-09T05:00:00Z,2014,12,2014-12-09T05:00:00Z,,2020-02-07T18:40:50Z,,0,0,0900006481969a5f
FDA-2014-D-1814-0001,FDA,FDA-2014-D-1814,"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",Notice,Notice of Availability,2014-12-09T05:00:00Z,2014,12,2014-12-09T05:00:00Z,2015-02-10T04:59:59Z,2015-01-04T02:57:01Z,2014-28809,0,0,09000064819681fe