How are combination products regulated under federal law?

Combination products are regulated under federal law based on their primary mode of action, which means that the determination of how they will be regulated hinges on which component—the drug, device, or biological product—plays the most significant role in achieving the intended therapeutic effect. This classification is essential because it directs the oversight and regulatory processes that the product will need to meet.

For example, if a combination product is primarily intended to diagnose, prevent, or treat a disease and the drug component is deemed to be the primary mode of action, it will be regulated as a drug. Conversely, if the device aspect is primary, the product will be treated under medical device regulations. The FDA has established clear guidelines to help manufacturers determine the primary mode of action, which emphasizes the importance of this classification system in ensuring that combination products meet the necessary standards for safety and efficacy.

The other options do not accurately reflect the regulatory framework for combination products. Regulation based solely on the manufacturer’s preference undermines the structured approach necessary for ensuring public safety. Likewise, classifying all combination products exclusively as drugs or only as medical devices overlooks the complexity and diversity present in these products, which can possess multiple functions and components. Thus, the primary mode of action serves as the critical basis for