Devices Implanted or Applied to Subjects Guidance

A medical device is something intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure of any function of the body without achieving its primary purpose through chemical action or via metabolization.

Examples of devices include:

• Daily wear contact lenses and associated lens care products not intended for use directly in the eye (e.g., cleaners; disinfecting, rinsing, and storage solutions)
• Jaundice monitors for infants
• Catheters
• Gas machines for anesthesia or analgesia
• Pacing leads
• Sutures

For more information:

• Control of Test Articles Used in Research Policy
• FDA device guidance