Does the definition of a drug include medical devices?

The definition of a drug, according to the Food, Drug, and Cosmetic Act, specifically refers to substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. This definition does not encompass medical devices, which are regulated separately because they are intended for use in diagnosing or treating conditions but do not achieve their effects through chemical action within the body like drugs do.

Medical devices include a wide range of products, such as surgical instruments, pacemakers, and imaging equipment, all of which do not fit the criteria of a drug. Therefore, since medical devices are classified distinctly and are intended for different purposes than pharmaceuticals, they fall outside the definition of a drug. This assists in clarifying regulatory pathways and safety standards that are specific to each category.

The alternative options relating to specific contexts or FDA regulation do not apply, as the fundamental definition remains clear and separate for drugs and devices regardless of contextual considerations or additional oversight.