FDA regulations generally require IRB review and approval of research involving FDA regulated products (e.g., investigational drugs, biological products, and medical devices) (21 CFR 56).
FDA developed its Bio Research Monitoring (BIMO) Program to ensure the protection of the rights, welfare, and safety of human subjects and the quality and integrity of data submitted to the Agency. Among other things, the FDA BIMO Program involves site visits to IRBs, clinical investigators, sponsors, monitors, contract research organizations, nonclinical (animal) laboratories, and bioequivalence analytical laboratories. This document addresses site visits to IRBs that review clinical investigations that are regulated by FDA under 21 USC 355(i) and 21 USC 360(j) and clinical investigations that support applications for research or marketing permits for products regulated by FDA.
