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    Combination Product

    Product comprised of two or more regulated components - e.g., drug-device, biologic-device.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    Per 21 CFR 3.2(e), a combination product is composed of two or more different types of medical products (drug, device, biologic) that are physically, chemically, or otherwise combined or co-packaged.

    What this means in practice

    FDA assigns a lead center based on the product's primary mode of action. Combination products must comply with both drug GMPs and device QSR/QMSR via streamlined cGMP requirements at 21 CFR Part 4.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    FDA·1eCFR·1European Commission·1
    1. 1
      Combination Products
      Verified
      FDAfda.gov
    2. 2
      21 CFR Part 4
      Verified
      eCFRecfr.gov
    3. 3
      European Commission - Medical Devices
      Verified
      European Commissionhealth.ec.europa.eu

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