Types of Combination Products

by | Apr 21, 2022 | Compliance, Consulting Group, FDA, Pharmaceuticals, Quality, Regulatory, Standardization, Standards

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.

__________________

[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

Sarah Koehler

Sarah Koehler

Sarah is a Quality Engineer at EMMA International. She has experience in quality assurance, change management, laboratory controls, and process/equipment validation within the pharmaceutical and medical device industry. Sarah has earned a Bachelor of Science in Chemical Engineering from Western Michigan University.

More Resources

FDA Adverse Event Reporting 

FDA Adverse Event Reporting 

When reporting an Adverse Event to the Food and Drug Administration (FDA) the best method is to utilize the FDA Adverse Event Reporting System (FAERS). FAERS is a database that contains adverse event reports, product quality complaints that led to an adverse event, and medication error reports1. All FAERS reports are easily accessible to the public. 
De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.

Ready to learn more about working with us?

Pin It on Pinterest

Share This