FDA Issues Draft Guidance on Export Certificates for Devices

The FDA released a new draft guidance on its review process for a Certificate to Foreign Government (CFG) and listed the reasons it may deny a request. Read More

AdvaMed Takes Issue With FDA Guidance on Humanitarian Device Exemption

AdvaMed said it strongly supports the FDA’s efforts to provide clarity around “probable benefits” from marketing authorizations for humanitarian use devices,… Read More

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