There are three types of combination products:
- Single entity
- Co-packaged or kits
- Cross-labeled
A single entity is a product comprised of two or more regulated components that are physically, chemically, or otherwise combined or mixed and produced as a single entity.
Examples include:
- Drug-eluting stents
- Prefilled syringes
- Transdermal patches
- Bone void fillers with drugs
Co-Packaged or Kit Combination Products
Co-packaged or kit combination products consist of two or more separate products packaged together in a single package or as a unit and comprised of drug plus device products, device plus biological products, or biological plus drug products. Examples include:
- First-aid or surgical kits
- Syringe packaged with vial of drugs
- Toothbrush packaged with fluoride toothpaste
Cross-Labeled Combination Product
A cross-labeled combination product is a drug, device or biological product packaged separately that according to its proposed labeling is intended for use only with an approved individually specified drug, device or biological product. Examples include:
- Certain light-emitting devices and light-activated drugs
- Certain imaging devices and imaging agents
