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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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70 rows where docket_id = "FDA-2014-D-1814" and posted_year = 2016 sorted by posted_date descending

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  • 2016 · 70 ✖

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-2014-D-1814-0103 FDA None FDA-2014-D-1814 Attachment 1 FDA Draft Guidance: Apheresis and Pre-Storage Pooled Platelets re: Comment from New York Blood Center (NYBC) Supporting & Related Material Background Material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 None 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 None 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 None 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FDA-2014-D-1814-0101 FDA None FDA-2014-D-1814 Attachment 1: Draft Guidance Bacterial Risk Control Strategies Markup re: Comment from Verax Biomedical (Verax) Supporting & Related Material Background Material 2016-06-14T04:00:00Z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FDA-2014-D-1814-0098 FDA None FDA-2014-D-1814 Attachment 1 Draft Guidance for Industry Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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

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