FDA Enforcement Overview Agency Overview FDA regulates > 20 of - PowerPoint PPT Presentation

FDA Enforcement Overview

Agency Overview • FDA regulates > 20¢ of every $1 spent by U.S. consumers • The Agency has enforcement roots • Has the only federal law enforcement agency exclusively devoted to public health (OCI) • 16,738 total employees (FY 2015 Budget Justification) CDRH: 1,723 ORA: 5,250 CDER: 4,508 2

Product Types: Low-Hanging Fruit • Software (e.g., mobile apps, cloud apps) • Miscellaneous consumer products (e.g., “vision trainers”, “balance trainers”) • Dietary supplements • Food • Cosmetics 3

Agency Overview FDA Structure Office of the Commissioner Office of Foods and Vet Med Office of Global Regulatory Operations and Policy Office of Medical Products and Tobacco CFSAN CVM CDER CBER CDRH CTP ORA OCC

Primary Enforcement Resources

Primary Enforcement Resources

Primary Enforcement Resources Par Park Doct k Doctrine ne

FDA Enforcement Overview