FDA Regulation of Blood and Blood Components in the United States
Overview of the Office of Blood Research and Review, and its regulatory review of blood and blood products, including discussion of in vitro diagnostic devices, Class II and III devices, blood collection, and source plasma.
Medical Device Review at CBER
Detailed discussion on the regulatory process for medical devices at CBER, a review of definitions, explanation of why the Center for Biologics reviews devices, and reporting requirements.
Blood Screening IVDs
Discussion on blood screening in vitro diagnostics, including safety, required screening/testing, and a brief discussion on the Investigational New Drug application (IND)/Biologics License Application (BLA) process.