Vaccines, Blood, Biologics FAQs Share Tweet Linkedin Email Print Importing Biologics What information do I need to import a biological product for research use only? How do I import a biological product regulated by FDA? Devices Regulated by CBER What medical devices does CBER regulate? Where can I find a list of devices approved/cleared by CBER? Registration Basics I work in a hospital transfusion service - do we need to register with FDA? How do I register my HCT/P establishment? How do I register my blood establishment? What is the status of my registration? General Information What should I do if the FDA form I need to use has expired? Where can I get information on donor eligibility for human cells, tissues and cellular- and tissue-based products (HCT/Ps)? Where can I find information on whether or not I need to file an IND application for a biological product?