The FDA Concept of Interest (COI) refers to the scientific and regulatory framework used by the U.S. Food and Drug Administration (FDA) to evaluate the safety and efficacy of medical products. The COI provides a basis for the FDA’s decision-making process, including the approval or rejection of medical products for marketing and use in the United States.
The COI is based on the concept that medical products should be evaluated based on the degree to which they meet specific criteria, such as safety, efficacy, and quality. The COI considers the benefits and risks of a medical product and takes into account the intended use of the product, the target population, and the available scientific data. The COI also considers the impact of the medical product on public health and the need for additional scientific evidence to support its use.« Back to Glossary Index