Module 1 2021

Center for Biologics Evaluation and Research (CBER) CENTER DIRECTOR: Peter W. Marks, MD, PhD Website: https://www.fda.gov/vaccines-blood-biologics

Offices: •

OFFICE OF MANAGEMENT

• OFFICE OF COMPLIANCE AND BIOLOGICS QUALITY • OFFICE OF BLOOD RESEARCH AND REVIEW • OFFICE OF CELLULAR, TISSUE, AND GENE THERAPIES • OFFICE OF VACCINES RESEARCH AND REVIEW • OFFICE OF COMMUNICATION, OUTREACH AND DEVELOPMENT • OFFICE OF BIOSTATISTICS AND EPIDEMIOLOGY

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Center for Devices and Radiological Health (CDRH) • Center Director: Jeffrey Shuren, MD, JD • Devices: primary intended purposes not through chemical action within or on the body − Classification

− 510K − PMAs • Radioactive products • Diagnostics − Companion diagnostics • Combination products

− Drug-device combination products − Biologics-device combination products

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