federal_register: 2017-28043

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2017-28043 Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled "Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers; Draft Guidance for Industry." The draft guidance document provides blood establishments that collect or process blood and blood components with recommendations for implementing pathogen reduction technology in the manufacture of pathogen-reduced blood components. The guidance also provides answers to frequently asked questions concerning the implementation of the INTERCEPT[supreg] Blood System for Platelets and Plasma. The recommendations apply to licensed blood establishments that intend to manufacture pathogen-reduced blood components using an FDA approved pathogen reduction device. 2017-12-27 2017 12 https://www.federalregister.gov/documents/2017/12/27/2017-28043/implementation-of-pathogen-reduction-technology-in-the-manufacture-of-blood-components-in-blood https://www.govinfo.gov/content/pkg/FR-2017-12-27/pdf/2017-28043.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 "Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers; Draft...

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