Device Resources

Two Investigational Applications for One Drug Product? IVD Device Requirements

A New Draft Guidance Provides In Vitro Diagnostic Device Requirements That May Impact Therapeutic Drug Trials Did you know that an assay used in a clinical trial designed to study an investigational drug may be considered an investigational In Vitro Diagnostic (IVD) Device, and therefore subject to the requirements of an Investigational Device Exemption (IDE)? […]
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