You may have heard the term ” combination products“, but what are they? The FDA currently defines them as any combination of two or more regulated components. Regulated components are typically drugs, devices, or biological products.
While drugs, devices, and biological products are meant to be examples of components that make up combination products, they are the only three components to have been labeled as combination products. Finding an appropriate definition has proved difficult, and the U.
S. is actually the only country to have a legal definition. Every other country in the world uses guidance documents because combination products are simultaneously broad and narrow in scope.
That’s why combination products are easier to understand through examples. For example, a vaccine that is prepackaged in a syringe would be a combination product. Any medicine that’s prefilled in a delivery system is a combination product, like inhalers or insulin injector pens. A first aid kit that includes drugs like acetaminophen and devices like bandages are considered combination products as well.
Understanding combination products is difficult for people not in the field because its definition is complex. You can watch the video above for more detailed information, or check out the FDA’s website.