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Regulatory Classifications

Meaning

Regulatory classifications are the formal, legally defined categories assigned by governmental health agencies, such as the FDA or European Medicines Agency, to various health products, including pharmaceuticals, medical devices, and dietary supplements, based on their intended use, mechanism of action, and the level of risk they pose to the public. These classifications, such as Drug, Biologic, or Class I/II/III Medical Device, dictate the specific pre-market approval requirements, manufacturing standards, and post-market surveillance protocols that must be rigorously followed. They are the gatekeepers of patient safety and product quality.