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Business · 23/04/2013Updated: 10/17/2026 · 1 min read

FDA Releases Draft Guidance on ISO-10993 for Medical Device Evaluation

Summary

The Food and Drug Administration (FDA) has released a draft guidance document to assist industry in evaluating the potential toxicity of medical devices that come into direct or indirect contact with the human body, using the International Standard ISO-10993.

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

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