“Learn about combination products—innovative healthcare solutions that combine drugs, devices, and biological products. Discover FDA guidelines, examples, and the future of combination products in advancing patient care.”
Combination Products: The marriage of drug and device
Innovation in healthcare has no limits, especially now. With the further advancements in medical science, more opportunity exists to develop game-changing products that connect two spheres of medicine. Among these innovations, the combination product has gained considerable attention from researchers in recent years. Integration of features and functions of drugs, devices, and biological products combination products have transformed approaches to diagnosis and treatment. In this article, we will take an in-depth look at what combination products are, their classification as well as a few examples from the real world.
Defining Combination Products
The U.S. Food and Drug Administration (FDA), the leading regulatory agency for healthcare in the United States, defines a combination product as “a product comprised 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 biological product.”
For some additional context, the FDA has identified four primary classifications for when a product qualifies as combination:
Combination Product with Same Entity
This form of a combination product consists of two or more components regulated as drug/device, biologic/device, drug/biologic, or drug/device/biologic Physically, chemically or otherwise assayed(s)combined together into a unit. In other words, they become too closely tied to each other to be considered as separate products. For instance, a monoclonal antibody with a therapeutic drug.
Combination Product Packaged Together
What is a Co-Packaged Combination Product? Co-packaged combination products consist of two or more separate regulated products packaged together in a single package or single unit (two examples are a drug with its delivery device). These combinations include drug and device products, device and biological products, or biological and drug products. As an example, this includes a vial of drug or vaccine packaged along with a delivery device.
Combination Product with Cross-Labeled Components
A drug, device, or biological product is packaged separately but is only supposed to be used in a combination with an individually specified approved drug, device or biological product — this falls under the category of compatible use. The two products together are required to accomplish the intended use, indication or effect. The labeling of the approved product may need to be amended upon approval to reflect this combination. For example, it includes a photosensitizing agent and an activating laser/light source.
A Different Type of Cross-Labeled Combination Product
Like the previous category, this one is for combination products where its investigational products are packaged separately but only when intended using a different specified investigational drug (or device or biological product). Both are required to provide the intended use, indication or effect.
Real-World Examples
With that in mind, let us all take off our combination products for a minute, and listen (or read rather) as we review some real-world examples of each category and why they matter:
Combination Products with a Single Entity
Drug-Eluting Stent: A stent that is coated with a drug to temporarily deliver the medicine, which keeps arteries from re-clogging after opening them.
Transdermal Patch: A patch that delivers drug over time to provide a constant blood concentration level
Prefilled drug delivery systems: Devices such as preloaded syringes or insulin injector pens designed to make the administration of these drugs simpler.
Combination Products that are Co-packed
First-Aid Kits: Kits combine devices like bandages and gauze with drugs like antibiotic ointments and pain killers.
Surgical Trays: Surgical trays contain an assortment of surgical instruments, drapes, and may also include anesthetic or antimicrobial swabs.
Combination Products with Cross-Labeling
Compounds that are used as a photosensitizing drug in conjunction with a specific laser/light source in certain medical procedures, including the treatments requested herein, but are sold together or separately only under specified conditions of use.
Conclusion
Combination products have played a critical role in the advancement of healthcare, creating a more effective and practical combination of drugs, devices, or biological products for patients. These complex products provide novel treatment, diagnostic and care options paving the way for the evolution of the healthcare industry in its pursuit to enhance patient clinical outcomes and quality of life. With the continuous evolution of technology and advancements in our understanding of medicine, combination products will expand and innovate further into the future for a healthier, happier world.
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