Clinical Investigation (FDA Definition)

Glossary Term:

Clinical Investigation (FDA Definition)

Definition

Use of a drug or medical device other than the use of an approved drug or medical device in the course of medical practice, when data will be gathered, submitted to, or held for inspection by the FDA in support of an FDA marketing permit for a food, including a dietary supplement that bears a nutrient content claim or a health claim, and infant formula, a food or color additive, a drug for human use, a medical device for human use, a biological product for human use, or an electronic product.