Food and Drug Administration
The U.S. Food and Drug Administration (FDA) regulates the safety, effectiveness, and security of human and veterinary drugs, biologics, medical devices, food and food additives, cosmetics, and radiation emitting devices. The FDA is a division of the U.S. Department of Health and Human Services.[1]
FDA Organization
Source: FDA, Jan. 2023[2]
What Does the FDA Regulate?
| Category | Examples | Regulatory Office |
| Biologics | Allergenics
Blood and blood products Cellular and gene therapy products Tissue and tissue products Vaccines |
Center for Biologics Evaluation & Research (CBER) |
| Cosmetics | Color additives in cosmetics
Hair products Makeup Nail polish and perfume Skin moisturizers and cleansers |
Center for Food Safety and Applied Nutrition (CFSAN) |
| Drugs | Non-prescription drugs
Prescription drugs |
Center for Drug Evaluation and Research (CDER) |
| Foods | Bottled water
Dietary supplements Food additives Infant formulas Other food products |
Center for Food Safety and Applied Nutrition (CFSAN) |
| Medical Devices | Complex devices (e.g., pacemakers)
Dental devices Prosthetics Simple devices (e.g., bedpans) Surgical implants |
Center for Devices and Radiological Health (CDRH) |
| Radiation Emitting Electronic Products | Laser products
Mercury vapor lamps Microwave ovens Sunlamps Ultrasonic therapy equipment X-ray equipment |
Center for Devices and Radiological Health (CDRH) |
| Tobacco | Cigarettes and cigars
E-cigarettes Hookah Roll-your-own tobacco Smokeless tobacco |
Center for Tobacco Products (CTP) |
| Veterinary Products | Pet foods
Livestock feeds Veterinary drugs and devices |
Center for Veterinary Medicine (CVM) |
Grants Opportunities
FDA posts all grant and assistance opportunities on Grants.gov.[5]
Procurement Opportunities
The Office of Acquisition & Grants Services (OAGS) is responsible for administration of all contracts and grants across FDA, including issuance of payment to vendors. [6]
Small Business Specialist, FDA Office of Small and Disadvantaged Business Utilization
AWL RMONR
Silver Spring, MD 20705
Natasha Boyce
301-796-3145
FDA also holds an annual Small Business Outreach Vendor Fair. FY2023’s presentation slides and event recordings offer tips for doing business with FDA and are available on the FDA website.
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