21 CFR 3.2(e) defines a Combination Product as one comprised of any combination of the following Constituent Parts:
- Drug and Device
- Biological Product and Device
- Drug and Biological Product
- Drug, Device and Biological Product
Some examples of combination products include:
- Pre-filled syringes
- Insulin injector pens
- Metered dose inhalers
- Transdermal patches
- Drug eluting stents
- Catheters with antimicrobial coatings
- Infusion pumps
- Medicated wound treatments
- Therapeutic orthopedic implants