Combination products are composed of two or more regulated components such as drug/device, biologic/device, drug/biologic, or drug/device/biologic. These components can be physically packaged together as one combination product, or chemically combined as a single entity. Some examples of combination products are drug-eluting coronary stents, antimicrobial coated catheters, and vaccines or biologic product in a pre-filled syringe.
When the principal mode of action of the combined product is device-like, then the regulatory filings will be managed by the Center for Devices and Radiological Health (CDRH), which then will be the “lead” Center. Device regulations will be followed, but additional requirements related to the secondary component will also need to be met. Conversely, when the primary action is pharmaceutical, the regulatory oversight will be managed by the Center for Drug Evaluation and Research (CDER), or the Center for Biologics Evaluation and Research (CBER), with the appropriate regulatory requirements appropriate for the device components also being met.