federal_register: 2014-28809
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2014-28809 | 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Collection Establishments and Transfusion Services To Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Bacterial Detection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 The draft guidance document provides blood collection establishments and transfusion services with recommendations for initial testing (primary testing) for bacterial contamination of platelets intended for transfusion, and provides additional considerations for blood collection establishments and transfusion services for subsequent retesting (secondary testing) of platelets prior to transfusion. The recommendations for primary testing of platelets and the additional considerations for secondary testing of platelets described in this guidance are expected to enhance the detection of bacteria in platelet products and thus enhance transfusion safety. The draft guidance, when finalized, is intended to supersede the recommendation in section VII.A.2, in regard to bacterial contamination testing in the document entitled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. | 2014-12-09 | 2014 | 12 | https://www.federalregister.gov/documents/2014/12/09/2014-28809/bacterial-detection-testing-by-blood-collection-establishments-and-transfusion-services-to-enhance | https://www.govinfo.gov/content/pkg/FR-2014-12-09/pdf/2014-28809.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for... |