FDA (U.S. Food and Drug Administration) approval

FDA approval is a formal process where the U.S. Food and Drug Administration reviews scientific evidence to ensure a medical product—like drugs, medical devices, or vaccines—is safe and effective for its intended use. This involves rigorous testing, clinical trials, and data analysis. Once approved, the product can be marketed and used in the U.S., but ongoing monitoring continues to ensure its safety. FDA approval doesn't mean a product is completely risk-free, but it signifies that the benefits outweigh the potential risks based on current evidence.