FDA's UDI guidance 'ambiguity' could lead to inconsistent implementation

Retrieved on: 2025-10-14 17:02:54

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Regulation of medical devices

Unique Device Identification

Regulation (EU) 2017/745

Medical device

AdvaMed

Food and Drug Administration

Unique Device Identifier

Regulation (EU) 2017/746

Global Medical Device Nomenclature

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FDA's UDI guidance 'ambiguity' could lead to inconsistent implementation. View article details on hiswai:

Excerpt

The perceived ambiguity of the US Food and Drug Administration's (FDA) guidance on Unique Device Identifier (UDI) requirements for combination medical ...

Article found on: www.medicaldevice-network.com

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