Combination products have components that fit into two different regulatory divisions such as drug/device, biologic/device, drug/biologic, or drug/device/biologic. These components can be physically packaged together as one combination product, or they may be chemically combined as a single entity.
When the principal mode of action of the combined product is device-like, then the regulatory filings of the combination product will be managed by the Center for Devices and Radiological Health (CDRH), which then will be referred to as the “lead” Center. The regulations for devices will be followed, but additional requirements related to the secondary component will also need to be met to support the regulatory submission. Conversely, when the primary action is to achieve a pharmaceutical purpose, then the regulatory oversight of the combination product will be managed through the Center for Drug Evaluation and Research (CDER), or through the Center for Biologics Evaluation and Research (CBER), but regulatory requirements appropriate for the device components must also be met.