The Food and Drug Administration (FDA) regulates several health products falling under the definitions of drugs, devices, cosmetics, household/urban hazardous substances, and food.
Due to the development of an increased variety of health products, the Agency has encountered health products that share similar characteristics or are considered “borderline” between the different product categories.
Task Force Diomede aims to focus on streamlining the process of classification of borderline health products.
An FDA Circular is currently being finalized by the Task Force so that the industry stakeholders shall be guided in the determination of the categories of health products prior to application for product registration.