A combination product is a product composed of two or more regulated components. Examples of combination products include but are not limited to the combination of components, such as drug and medical device or biologic and drug, that are combined and produced as a single entity or products packaged together as a unit1. A product package containing drug and drug product, or device and device are not combination products, there are 9 different types of known combination products approved by the Food and Drug Administration (FDA).
The known types of combination products are as follows:
- Convenience Kit/Co-Package
- Prefilled Drug Delivery Device or System
- Prefilled Biological Delivery Device or System
- Device Coated/Impregnated with a Drug
- Device Coated with a Biologic
- Drug and Biologic combination
- Separate Products requiring Cross Labeling
- Possible Combination based on Cross Labeling of Separate Products
- Other Types of Part 3 Combination Products (Drug/device/biologic)
The common combination products include the convenience package, prefilled drug delivery device, prefilled biologic delivery device, and device coated with a drug or biologic. A device coated with biologic or drug includes but is not limited to pills embedded with a sensor, drug-eluting stents, dental floss with fluoride, bone cement, and live cells seeded in a device scaffold. Prefilled biologic delivery devices are very common as vaccines, prefilled syringes, nasal sprays, and prefilled microneedle patches fall into this group.
Convenience Kits and Co-packaged combinations products include Drug/Biologic products that are packaged with a device or accessory kits such as preparation H or surgical kits containing drugs and a device. Another common combination product is Prefilled drug delivery devices such as auto-injectors, metered-dose inhalers, nasal sprays, pumps, and prefilled drug syringes1. If your company needs assistance with approvals, identification, and classifications of combination products, EMMA International is here to help. Contact us by phone at 248-987-4497 or by email at info@emmainternational.com.
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[1] FDA (February 2018) Combination Product Definition Combination Product Types. Retrieved on April 19, 2022, from https://www.fda.gov/combination-products/about-combination-products/combination-product-definition-combination-product-types
