FDA – U.S. Food and Drug Administration Compliance

1. Definition

The U.S. Food and Drug Administration (FDA) is a federal agency under the U.S. Department of Health and Human Services (HHS) responsible for protecting public health by regulating:

• Food and beverages

• Pharmaceuticals

• Medical devices

• Cosmetics

• Dietary supplements

• Tobacco products

2. Purpose and Scope

FDA compliance ensures that products are safe, effective, and truthfully labeled before being marketed or sold in the United States.
Its mission includes:

• Safeguarding the safety and quality of food and medical products.

• Promoting innovation and scientific standards.

• Enforcing Good Manufacturing Practices (21 CFR Parts 210–211) for drugs and medical devices.

3. Key Areas of FDA Regulation

• Food Safety Modernization Act (FSMA)

• Drug Quality and Security Act (DQSA)

• Medical Device Regulations (21 CFR Part 820)

• Cosmetics and Labeling Requirements (FD&C Act)

• Biologics and Vaccines Regulation

4. Benefits of FDA Compliance

• Legally required for access to the U.S. market.

• Demonstrates product safety, authenticity, and quality.

• Enhances brand credibility and global market acceptance.

• Reduces risks of enforcement actions, fines, or product recalls.

5. Conclusion

FDA compliance ensures that organizations meet the highest standards of safety, quality, and integrity, protecting consumers while supporting responsible innovation and global trade.