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Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use (US Food and Drug Administration Regulation) (FDA) (2018 Edition)

eBook details

Title: Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use (US Food and Drug Administration Regulation) (FDA) (2018 Edition)
Author : The Law Library
Release Date : January 17, 2018
Genre: Law,Books,Professional & Technical,
Pages : * pages
Size : 677 KB

Description

The Law Library presents the complete text of the Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use (US Food and Drug Administration Regulation) (FDA) (2018 Edition).
Updated as of May 29, 2018

The Food and Drug Administration (FDA) is amending the regulations applicable to blood and blood components, including Source Plasma, to make the donor eligibility and testing requirements more consistent with current practices in the blood industry, to more closely align the regulations with current FDA recommendations, and to provide flexibility to accommodate advancing technology. In order to better assure the safety of the nation's blood supply and to help protect donor health, FDA is revising the requirements for blood establishments to test donors for infectious disease, and to determine that donors are eligible to donate and that donations are suitable for transfusion or further manufacture. FDA is also requiring establishments to evaluate donors for factors that may adversely affect the safety, purity, and potency of blood and blood components or the health of a donor during the donation process. Accordingly, these regulations establish requirements for donor education, donor history, and donor testing. These regulations also implement a flexible framework to help both FDA and industry to more effectively respond to new or emerging infectious agents that may affect blood product safety.

This ebook contains:
- The complete text of the Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use (US Food and Drug Administration Regulation) (FDA) (2018 Edition)
- A dynamic table of content linking to each section
- A table of contents in introduction presenting a general overview of the structure