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Many companies don’t realize they have a combination product until it’s too late. With increased regulatory scrutiny from the FDA, properly identifying your product type is not just important—it’s essential for compliance, market access, and patient safety.
A combination product, as defined by the FDA, is a therapeutic and diagnostic product that combines drugs, devices, and/or biological products. These products can take multiple forms, including:
- Prefilled syringes (drug + delivery device)
- Drug-eluting stents (device coated with a drug)
- Convenience kits (e.g., vials packaged with filters and needles)
- Cross-labeled products (e.g., drug and device sold separately but intended for combined use)
Some of these combinations are obvious, but many are not. A product that seems like simple packaging may actually trigger combination product regulations under FDA’s 21 CFR Part 4, effective since 2013. The FDA began strict enforcement in 2014, prompting many companies to reevaluate their portfolios.
One of the biggest risks is operating under outdated assumptions. If your company has historically marketed a device or drug in conjunction with another regulated product, you may already be in combination product territory without knowing it.
If there’s uncertainty, the FDA allows companies to submit a Request for Designation (RFD). This formal process helps determine which regulatory center (CDER, CBER, or CDRH) will have primary jurisdiction over your product based on its primary mode of action (PMOA).
Identifying whether your product qualifies as a combination product is a foundational step. Doing so early allows for proper planning of your development pathway, avoids regulatory surprises, and helps build a robust compliance strategy.
Partner with Regulatory Experts Regulatory Compliance Associates (RCA) has extensive experience helping companies identify and navigate combination product requirements. Contact RCA today to ensure you’re on the right path from the start.
