How do IVD devices differ from other devices?
Most other devices function on or in a patient. In contrast, IVDs include products used to collect, prepare, and examine specimens (e.g., blood, serum, urine, spinal fluid, tissue samples) after they are removed from the human body. • Which Divisions at FDA are responsible for review of IVD products? Center for Devices and Radiological Health (CDRH) • Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) • Division of Chemistry and Toxicology Devices – Phone: (240) 276-0443 • Division of Immunology and Hematology Devices – Phone: (240) 276-0493 • Division of Microbiology Devices – Phone: (240) 276-0496 Center for Biologics Evaluation and Research (CBER) • Office of Cell, Tissues, and Gene Therapy (OCTGT) – Phone: (301) 827-5102 • Office of Blood Research and Review (OBRR) • Division of Blood Applications (DBA) – Phone: (301) 827-3524 DBA schedules all review-related meetings for OBRR • Division of Emerging and Transfusion Transmitted Diseases (DETTD) – Phone: (301) 827-3008
