Combination Product Services

We understand the device, what's inside, and how they interact. Our subject matter experts have the experience to be your end-to-end product and process development team.

Development & Operations

  • • Product & Process Development
  • • CMC Services & Analytical Sciences
  • • Process Engineering
  • • MS&T and Supply Chain
  • • Human Factors Regulatory & Strategy (HURAS)
  • • Packaging Technology & Engineering
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    Quality, Regulatory, & Compliance

  • • Quality Assurance, Compliance & Auditing
  • • Quality Engineering
  • • Quality Control
  • • Regulatory Affairs
  • • Clinical & Medical Affairs
  • • CGxP Microbiology & Environmental Monitoring
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    Commissioning, Qualification, & Validation

  • • Validation Master Planning
  • • Facilities & Utilities CQV
  • • Lab & Plant Equipment CQV
  • • Computer System Validation (CSV)
  • • Process Validation
  • • Cleaning Validation
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    Strategy, Planning, & Execution

  • • Program & Project Management
  • • Technology Transfer
  • • Innovation Solutions
  • • Enterprise Resource Planning & Solutions
  • • Due Diligence
  • • Staffing Solutions
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    Combination Products & Services Where We Excel

    Injectables 

    Injectables

      • Prefilled Syringes (PFS)
      • Mechanical and
      Electromechanical Autoinjectors
      • Wearable Injectors
      • Dual Chamber Systems
      • Reconstitution Systems

    Respiratory

    Respiratory

      • Metered Dose Inhalers (MDI)
      • Dry Powder Inhalers
      • Nasal Sprays

    eHealth

    eHealth

      • Connected Devices
      • Wearable Biosensors
      • Apps

    Other Combo Products

    Other Combo Products

      • Ocular
      • Intrathecal
      • Oral
      • And More!

    Kymanox Combination Product Resources

    6 Things Pharma Needs To Know About Combo Products

    Even though USA FDA 21 CFR Part 4 has been around for a while, the regulations on combo products are still not well understood. Here are six things pharmaceutical companies need to understand to avoid potential problems down the road. 

    The 9 Types Of Combination Products Defined By The FDA

    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. 

    Meet our Combination Product Experts

    Jason Miller
    HEAD OF ENGINEERING
    Jason Miller
    Michael Denzer

    Frequently Asked Combination Product Questions (FAQs)

    What is a combination product?
    A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Under 21 CFR 3.2 (e), a combination product is defined to include: 
    1. A product comprised of two or more regulated components (i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic) that are physically, chemically, or otherwise combined or mixed and produced as a single entity [often referred to as a “single-entity” combination product];
    2. Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products [often referred to as a “co-packaged” combination product];
    3. A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where, upon approval of the proposed product, the labeling of the approved product would need to be changed (e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose) [often referred to as a “cross-labeled” combination product]; or
    4. Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect [another type of “cross-labeled” combination product].
    For more information on the nine types of combination, products see our infographic here.
    What are some examples of a drug-device combination product?

    Combination Products can be classified under three categories: co-packaged (constituent parts packaged and sold together), single-entry (chemically or physically combined constituent parts), or cross-labeled (constituent parts sold separately).

    Co-Packaged Products (21 CFR 3.2(e)2)

    • Empty syringes packaged with a drug product
    • Empty injection systems packaged with a drug product
    • Transfer sets
    • Surgical kits containing both a drug and a device to be used with it

    Single-Entity Products (21 CFR 3.2(e)(1)

    • Prefilled syringes
    • Prefilled auto-injectors
    • Metered-dose inhalers
    • Dry powder inhalers
    • Nasal-spray
    • Prefilled pumps
    • Transdermal patch systems
    • Drug pills embedded with sensors
    • Contact lens coated with a drug
    • Condoms with spermicide
    • Dental floss with fluoride
    • Antimicrobial coated catheters/sutures

    Separate Products With Cross-Labeling  (21 CFR 3.2(e)(3) or (e)(4)

    • Light-activated drugs/biological products labeled for use with a specific light source device

    For more information on the nine types of combination products see our infographic here.  
    I’m developing a combination product – do I need to submit separate applications for both the drug and the device?
    Some combination products can rely on a single application to gain regulatory approval; however, the following two main factors influence the decision on whether one or more applications are needed:
    1. The intended market – Whether the product is hitting the market in the United States of America (USA) or in the European Union (EU), each market has key differences.
    2. The type of combination product – there are regulatory differences for each type of combination product previously mentioned: single-entity/integral products, co-packaged products, or cross-labeled products
    What is a Primary Mode of Action and why is it important?
    The Primary Mode of Action (PMOA) is the main therapeutic component that defines the combination product’s intended use. For drug-device combination products, the primary intended use will be attributed to either the drug part or the device component of the combination product. In the USA, the different branches of the Food & Drug Administration (FDA) oversees each of these components. If the PMOA is attributable to the drug product, the FDA’s Center for Drug and Evaluation Research (CDER) would have primary jurisdiction for the combination product. On the other hand, if the PMOA is attributable to the device, the Center for Devices and Radiological Health (CDRH) would hold primary jurisdiction for the product. 
    Who are the governing agencies that set rules and requirements for combination products?
    In the USA, the FDA is the governing agency. In 2002, the FDA created the Office of Combination Products (OCP) to serve as a home base for all issues related to combination products. This office maintains compliance to all combination product related regulations and enforces the regulations outlined in the Current Good Manufacturing Practices (CGMP), which ensures that they are manufactured in a quality controlled environment. For the EU, the European Commission (EC) is the governing agency for combination products. Like the FDA’s OCP, the EC establishes and enforces regulations for combination products to ensure the safety of their residents.
    What are the current good manufacturing practices for combination products?
    The term current good manufacturing practice or CGMP refers to the current good manufacturing practice regulations for drugs and most biological products under 21 CFR Parts 210 and 211, for certain biological products under 21 CFR Parts 600-680, and the quality system regulations for devices under 21 CFR Part 820. For a complete guide to CGMP, visit the FDA website here.