The FDA’s updated guidance on Unique Device Identification (UDI) for combination products, updated as of June 2025, has stirred conversation across the industry. For companies developing products that merge drug, biologic, and device components, labeling has always been a regulatory gray zone. Now, the FDA’s latest updates, intended to clarify requirements, have left many manufacturers with new questions.

Why UDI Matters

At its core, UDI enables traceability throughout a product’s lifecycle, from manufacturing to patient use. For medical devices, this system has been well-established. But combination products blur the boundaries: a prefilled syringe, an auto-injector, or a drug-coated implant are all devices that contain a regulated drug or biologic.
The challenge lies in determining which component drives the labeling requirements and how UDI should be applied when multiple regulatory pathways intersect.

Key Points from the FDA’s Guidance

The FDA’s recent communication revisits several key areas:

1. Component vs. finished product labeling – Manufacturers must now consider whether each constituent part requires its own UDI or if a single identifier for the entire finished combination product is sufficient.

2. Cross-center coordination – The guidance attempts to bridge interpretations between CDRH, CDER, and CBER, yet does not fully resolve which center takes precedence when labeling requirements differ.

3. Transition timelines – The FDA emphasizes enforcement discretion, acknowledging that some manufacturers will require additional time to implement compliant labeling systems.

4. Electronic health record (EHR) integration – The Agency highlights the importance of capturing UDIs for combination products within EHRs and adverse event reporting, underscoring the downstream quality and safety implications.

Industry Response: Seeking Clarity

While the FDA aimed to simplify expectations, many industry stakeholders argue that ambiguity remains. For example, in auto-injectors containing biologic drugs, should the syringe barrel carry a device UDI while the outer carton reflects the drug’s National Drug Code (NDC)? What about kit-based systems where the components are manufactured separately but marketed together?

Several industry groups, including AdvaMed and PDA, have called for clearer cross-center examples that reflect real-world manufacturing and packaging scenarios. Without this clarity, firms risk inconsistent labeling interpretations – something that can trigger compliance findings during inspections or delay product launches.

Practical Considerations for Manufacturers

Given the uncertainty, manufacturers should take a risk-based approach:

• Start early: Evaluate how existing labeling systems accommodate combination products and map where device and drug labeling overlap.

• Engage regulatory affairs early: Coordinate between regulatory, quality, and labeling teams to ensure that both device and drug requirements are captured before final artwork.

• Document your rationale: When deciding whether to assign multiple UDIs, ensure your internal justification is well-supported and traceable through your Design History File (DHF) or combination product dossier.

• Monitor FDA enforcement trends: The Agency has historically allowed flexibility during transition periods, but formal enforcement could increase as UDI databases mature.

Final Thoughts

The FDA’s intent with this UDI guidance is clear: enhance traceability, support patient safety, and streamline recalls and reporting. Yet, the path forward for combination products remains complex.
Manufacturers should not view the ambiguity as a setback but as a reminder of the need for proactive cross-functional planning and strong internal governance.

As the Agency continues to refine its position (and as industry feedback accumulates) those who act early will be best positioned to adapt smoothly. Whether your product is an injection pen, a drug-eluting stent, or a diagnostic kit, understanding the evolving UDI expectations is key to sustaining compliance and market confidence.

How QSN Views the Road Ahead

At Quality Solutions Now (QSN), we view this guidance as an opportunity for companies to strengthen internal traceability frameworks and align global labeling practices. Many international regulators, including the EU’s MDR/IVDR, dhave already emphasized unique device identification systems. As global markets converge, building adaptable labeling governance will reduce the need for future rework.

The qsnFLOW™ methodology, which integrates quality, regulatory, and operational perspectives, helps clients anticipate these challenges early. Reach out to find out how Quality Solutions Now can help you stay ahead of evolving UDI requirements.