Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
Information
Type
Proposed Rule
Regulated products
Published
November 8, 2007
Last updated
November 8, 2007
Description
Document number E7-21565. The Food and Drug Administration (FDA) proposes to revise and update the regulations applicable to blood and blood components, including Source Plasma and Source Leukocytes, to add donor requirements that are consistent with current practices in the blood industry, and to more closely align the regulations with current FDA recommendations. FDA is taking this action to help ensure the safety of the national blood supply and to help protect donor health by 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.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)