Notice
26 Jun 2025
compliance, fda, medical devices, udi requirements, combination products
🏥Unique Device Identifier Requirements for Combination Products
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled "Unique Device Identifier (UDI) Requirements for Combination Products." This draft guidance is intended to assist industry and FDA staff in understanding how FDA's unique device identifier (UDI) requirements apply to combination products with device constituent parts.
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