FDA 510(k) Glossary · regulatory

Combination Product

A combination product is an FDA-regulated product that combines a medical device with a drug, biologic, or another device into a single entity. The FDA determines the primary mode of action to assign regulatory jurisdiction. Combination products cleared through the 510(k) pathway are flagged in device records in the 510k Database dataset.
Dataset Insight - 510k Database (166,200 records, 1980–2025)
The combination_product flag is populated for enriched records in the dataset, identifying submissions designated by the FDA as combination products requiring coordinated review.

Definition

Under 21 CFR Part 3, a combination product is a product comprised of two or more regulated components - such as a drug and a device, a biologic and a device, or a drug and a biologic - that are physically, chemically, or otherwise combined or mixed and produced as a single entity. The FDA's Office of Combination Products (OCP) assigns primary jurisdiction based on the product's primary mode of action (PMOA).

Common Examples

  • Drug-eluting stents - a cardiovascular device that releases a drug to prevent restenosis
  • Prefilled drug delivery systems - autoinjectors or prefilled syringes containing a biologic or drug
  • Photosensitizer + light source systems - used in photodynamic therapy
  • Antimicrobial wound dressings - device matrix combined with an antimicrobial agent

Regulatory Assignment

The FDA center with primary jurisdiction over a combination product depends on the primary mode of action:

  • CDRH (Center for Devices and Radiological Health) - if the device component provides the primary therapeutic action
  • CDER (Center for Drug Evaluation and Research) - if the drug component is primary
  • CBER (Center for Biologics Evaluation and Research) - if the biologic component is primary

510(k) Pathway for Combination Products

Combination products with a device primary mode of action may be reviewed through the 510(k) premarket notification pathway when substantial equivalence to a valid predicate device can be demonstrated. The submission must address device performance, drug/biologic safety and efficacy, and any interactions between components.

FDA References

Related Terms

510(k) Premarket Notification - Substantial Equivalence - Predicate Device - SaMD

Frequently Asked Questions

A combination product is a product that combines two or more types of FDA-regulated articles - such as a device combined with a drug or biologic. Examples include drug-eluting stents (device + drug), prefilled syringes (device + drug), and photodynamic therapy products (device + drug). The FDA determines which center (CDRH, CDER, or CBER) has primary jurisdiction based on the product's primary mode of action.

Combination products may be cleared through the 510(k) pathway if the device component is the primary mode of action and the product is substantially equivalent to a predicate. The submission must address both the device and non-device components and may require consultation between FDA centers.

The FDA Office of Combination Products (OCP) coordinates the review of combination products across FDA centers. Manufacturers can request a designation from OCP to determine which FDA center will have primary jurisdiction over their product.

The 510k Database dataset includes a combination_product flag extracted from FDA accessdata.gov for enriched records. This flag identifies submissions where the FDA has designated the product as a combination product requiring coordinated regulatory review.