FDA UDI Requirements for Combination Products

The U.S. FDA has released a draft guidance on FDA UDI Requirements clarifying how UDI requirements apply to combination products containing device constituent parts. These include single-entity, co-packaged, and cross-labeled products that combine drugs, biologics, and/or devices. 

Key Highlights

• Single-entity device-led combination products must bear a UDI and should not bear a National Drug Code (NDC). 
• Drug or biologic-led combination products that properly bear an NDC are not required to bear a UDI. 
• Co-packaged products must ensure UDI compliance either on the combination product or each device constituent part, depending on the product type and labeling. 
• UDI information must be submitted to the FDA’s Global Unique Device Identification Database (GUDID), unless exemptions apply. 

The guidance also outlines exceptions, labeling recommendations, and practical examples to help industry navigate compliance. 

How MedEnvoy Supports Compliance

MedEnvoy offers expert regulatory support to manufacturers of combination products in navigating FDA UDI requirements. 

If you have any questions regarding the above, we encourage you to reach out to our regulatory experts here.