federal_register: 2016-05718
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2016-05718 | 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Collection Establishments and Transfusion Services To Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled "Bacterial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Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry." The draft guidance document provides blood collection establishments and transfusion services with recommendations to control the risk of bacterial contamination of room temperature stored platelets intended for transfusion through the implementation of pathogen reduction technology (PRT) or bacterial testing. The draft guidance also provides recommendations for the use of secondary testing of platelets as the basis to extend the dating period of platelets, when appropriately labeled bacterial detection devices and storage containers are used. The draft guidance replaces the draft guidance entitled "Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion," dated December 2014. The draft guidance, when finalized, is intended to supersede the recommendation in section VII.A.2, in regard to bacterial contamination testing in the document entitled "Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods" dated December 2007. | 2016-03-15 | 2016 | 3 | https://www.federalregister.gov/documents/2016/03/15/2016-05718/bacterial-risk-control-strategies-for-blood-collection-establishments-and-transfusion-services-to | https://www.govinfo.gov/content/pkg/FR-2016-03-15/pdf/2016-05718.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled "Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of... |