How does the FDA define a medical device?

The FDA defines a medical device as an instrument, apparatus, implement, machine, or related article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. This definition is comprehensive and encompasses a wide range of products that are designed to aid in the medical field. Medical devices can include everything from simple tools like tongue depressors to complex machinery like MRI machines.

The essence of this definition lies in its focus on the intended purpose of the device, which must relate directly to patient diagnosis or treatment. This delineation is crucial in differentiating medical devices from other products, such as software applications or consumables that may serve health-related functions but do not meet the specific criteria of being used for medical purposes as defined by the FDA.

While software applications for health monitoring and electronic health record systems may be integral to patient care, they do not fit the FDA’s traditional classification of a medical device unless they are specifically designed to diagnose, cure, or treat a disease. Similarly, consumable products used in health facilities, while essential, do not specifically align with the FDA's definition of a medical device without the context of their intended use in medical diagnosis or treatment. Thus, this answer aptly captures the essence of the FDA's definition of a