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FDA Classification

Meaning

The formal categorization system employed by the U.S. Food and Drug Administration (FDA) to regulate and define the regulatory pathway for various medical products, including drugs, biologics, and medical devices, based on their intended use, risk profile, and required level of scientific evidence. This classification dictates the necessary standards for manufacturing, testing, labeling, and post-market surveillance, ensuring product safety and efficacy for the public. For hormonal therapies, the classification determines the stringency of clinical trials and approval processes.