Unique Device Identifier (UDI) Requirements for Combination Products (FDA Draft Guidance – June 2025)

In June 2025, the FDA issued a draft guidance clarifying Unique Device Identifier (UDI) labeling requirements for combination products — including single-entity, co-packaged, and cross-labeled products. This document outlines the agency’s current thinking, expectations, and examples. The guidance is open for public comment until September 24, 2025.

Summary of Key UDI Requirements

UDI Requirements by Combination Product Type

Combination Product Type	UDI Requirements for Combination Product	UDI Requirements for Device Constituent Part(s)	FDA Recommendations
Single-Entity Combination Products	Device-led: UDI on product satisfies requirement Drug-/biologic-led: No UDI required if it properly bears an NDC	N/A (no separate labeling)	Device-led: Should not bear an NDC Drug-/biologic-led: FDA recommends no UDI if NDC is properly present
Co-Packaged Combination Products	Device-led: UDI on product satisfies requirement Drug-/biologic-led: No UDI required if it properly bears an NDC	UDI required on each device constituent part unless: 1) It's excepted from UDI rules, or 2) The combo product itself bears a UDI (device-led only)	Device-led: Should not bear an NDC Drug-/biologic-led: Recommend UDI on each device constituent part, not on the combo product
Cross-Labeled Combination Products	N/A (no single combination product label)	Each device constituent part must bear a UDI (unless excepted)	N/A

💡 Reminder: All UDIs must be submitted to the Global Unique Device Identification Database (GUDID) unless exempted. Comments on the draft guidance can be submitted to the FDA here by September 24, 2025.

Official FDA Guidance Page (June 2025 Draft)

📄 Go to FDA's Official UDI Guidance Page

What Do You Think?

📢 Are you a combination product manufacturer or labeler? Let us know how this draft guidance could affect your compliance planning. Email us or comment on our LinkedIn page.