Unique Device Identifier Requirements for Combination Products; Draft Guidance for Industry and FDA Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled "Unique Device Identifier (UDI) Requirements for Combination Products." This draft guidance is intended to assist industry and FDA staff in understanding how FDA's unique device identifier (UDI) requirements apply to combination products with device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.
Abstract as published in the Federal Register.
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