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