FDA Combination Products: What They Are and Why They Matter

When a medical product combines a drug, a device, and/or a biological component into one unit, it’s called an FDA combination product, a regulated medical product that blends two or more types of therapies into a single entity. Also known as combined drug-device products, these aren’t just pills in a blister pack—they’re things like insulin pens with built-in dosing sensors, antibiotic-coated stents, or auto-injectors that deliver biologics. The FDA treats them differently than standalone drugs because they involve multiple regulatory pathways, and figuring out which center reviews them—CDER, CDRH, or CBER—can change how fast they reach patients. This matters because if you’re taking a product like a pre-filled syringe with a biologic, or a patch that releases medication over time, you’re using a combination product—and you deserve to know how it was tested and approved.

Combination products are everywhere in modern medicine. Think of the EpiPen: it’s not just an epinephrine injection, it’s a device designed to deliver it safely with one hand. Or the inhalers that combine bronchodilators with precise metered-dose mechanisms. Even some wound dressings that release antibiotics fall under this category. The FDA doesn’t just approve the drug part or the device part—it evaluates how they work together. That means safety isn’t just about side effects of the medicine, but also about whether the device delivers it correctly every time. This is why you’ll see references to the FDA Orange Book, a public database listing approved drug products with therapeutic equivalence evaluations in some posts—it’s where patent and exclusivity info for drug components lives, even if the full product is a combo. And when a company tries to extend its monopoly using orphan drug status or pediatric studies, those rules often apply differently to combination products than to plain pills.

What you’ll find in this collection are real-world examples of how these products affect your health. You’ll see how patent expirations for combo products create ripple effects in pricing, how manufacturers report safety issues differently when a device fails, and why some drugs get approved faster because they’re tied to a device that improves compliance. You’ll also learn how drug interaction checkers must account for combo products—because if your inhaler contains both a steroid and a bronchodilator, that’s not two separate drugs in your system, it’s one regulated unit. These aren’t abstract regulations. They’re the reason your asthma inhaler works reliably, why your insulin pen doesn’t leak, and why generic versions of complex products take longer to appear. The posts below dig into the tools, rules, and real-life impacts of these products—without the jargon. You’ll walk away knowing not just what FDA combination products are, but how they shape what’s in your medicine cabinet and why it matters for your care.