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Business · 16/12/2021Updated: 10/17/2026 · 1 min read

FDA Releases Draft Guidance on Device Definitions

Summary

The US Food and Drug Administration (FDA) has published a draft guidance document clarifying the definition of a 'device' in federal regulations, aiming to improve consistency in referencing devices and counterfeit devices across various public documents.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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