Devices

The Center for Biologics Evaluation and Research (CBER) regulates the medical devices involved in the collection, processing, testing, manufacture and administration of licensed blood, blood components and cellular products. CBER also regulates all HIV test kits used both to screen donor blood, blood components and cellular products, and to diagnose, treat and monitor persons with HIV and AIDs.

Approval Process and Related Information

Approved Products

Device Guidances, Rules and Other Publications

 

 
Updated: November 27, 2007