What differentiates a medical device from a drug?

The distinction that a medical device does not involve chemical action, whereas a drug does, is foundational in understanding how these two categories of products operate within the healthcare system. Medical devices are defined primarily by their functional characteristics; they achieve their intended purposes through physical means or mechanisms rather than by chemical action within the body. For example, devices may include items such as surgical instruments, implants, or diagnostic equipment, which perform their roles without altering the chemical composition of the body or the substances within it.

In contrast, drugs are substances that produce a physiological effect through chemical action in the body. They may alter bodily functions, such as altering metabolism or affecting a particular organ, often involving active ingredients that exert a specific biochemical effect.

This fundamental difference helps regulatory agencies categorize and regulate these products appropriately, ensuring that each type follows the necessary requirements for safety and efficacy relevant to its mode of action. Understanding this distinction is vital for professionals in regulatory affairs, as it informs compliance, labeling, marketing, and post-market surveillance strategies for these products.