How the FDA Defines Combination Products

Is your product a combination product?  Combination products are defined in 21 CFR 3.2(e) and more products than ever now fall into this category but many manufacturers are unaware of that fact nine types of combination products.  The FDA identifies.Take a look at the table below to see if your product might just be a combination product.

Type
Description
Common Example(s)
1

Convenience Kit or Co-Package

Drug and device are provided as individual constituent parts within the same package

Drug or biological product vials packaged with device(s) or accessory kits (empty syringes, auto-injectors, transfer sets), first aid or surgical kits containing devices and drugs
2

Prefilled Drug Delivery Device/ System

Drug is filled into or otherwise combined with the device AND the sole purpose of the device is to deliver drug

Prefilled drug syringe, auto-injectors, metered-dose inhalers, dry powder inhalers, nasal-spray, pumps, transdermal systems, prefilled iontophoresis system or microneedle “patch”
3

Prefilled Biologic Delivery Device/ System

Biological product is filled into or otherwise combined with the device AND the sole purpose of the device is to deliver biological product

Vaccine or other biological product in a prefilled syringe, autoinjector, nasal spray, transdermal systems or microneedle patch pre-loaded with biological product
4

Device Coated/ Impregnated/ Otherwise Combined with Drug

Device has an additional function in addition to delivering the drug

Drug pills embedded with sensors, contact lens coated with a drug, drug-eluting stents, drug-eluting leads, condoms with spermicide, dental floss with fluoride, antimicrobial coated catheters/sutures, bone cements with antibiotics
5

Device Coated or Otherwise Combined with Biologic

Device has an additional function in addition to delivering the drug

Live cells seeded on or in a device scaffold, extracorporeal column with column-bound protein
6
Drug/Biologic Combination
Antibody-drug conjugates, progenitor cells combined with a drug to promote homing
7
Separate Products Requiring Cross Labeling
Light-activated drugs or biological products not co-packaged but labeled for use with a specific light source device
8
Possible Combination Based on Cross Labeling of Separate Products
Drug/biological product under development utilizes a device, but   unclear whether the final product will require that the two be cross-labeled
9

Other Type of Part 3 Combination Product (e.g., Drug/Device/ Biological Product)

Combination product not otherwise described

All 3 articles are combined in a single product (e.g., a prefilled syringe containing an antibody-drug conjugate), device to manufacture a biologic also includes a drug or biologic in the kit, or the product contains two different combination product types (e.g., Type 1 and Type 2 are provided together
Is your product a combination product?  Combination products are defined in 21 CFR 3.2(e) and more products than ever now fall into this category but many manufacturers are unaware of that fact.  The FDA identifies nine types of combination products.  Take a look at the table below to see if your product might just be a combination product.

FDA Chart

Looking to keep your combination product development moving along?


A comprehensive process is needed to make sure your combination product development project finishes on time and on budget. This comprehensive checklist identifies the key phases and work packages to help you stay on track.


Download CP Checklist

Looking to keep your combination product development moving along?


A comprehensive process is needed to make sure your combination product development project finishes on time and on budget. This comprehensive checklist identifies the key phases and work packages to help you stay on track.


Download CP Checklist

Looking for some help with combination product development?  Kymanox provides turnkey services to bring your combination product from concept to commercialization.
Call us today at +1 919.246.4896 or email
info@kymanox.com.
Looking for some help with combination product development?  Kymanox provides turnkey services to bring your combination product from concept to commercialization.  Call us today at +1 919.246.4896 or email info@kymanox.com.