Who does what?
CBER oversees preparation of human cells, tissues, and cellular and tissue products (HCT/P's) that are regulated solely under section 361 of the PHS Act. For example, donor screening and good tissue practices.
CBER regulates HCT/P's regulated under section 351 of the PHS Act.
CDRH regulates HCT/P's that are classified as devices and regulated under the device provisions of the FD&C Act.
Many therapeutic biological products now regulated by CDER.
Combination products (biologic device; drug device, biologic - drug) are regulated based on their primary mode of action.