Home » FDA Finalizes Guidance on Device Humanitarian Use Designations
FDA Finalizes Guidance on Device Humanitarian Use Designations
The FDA Thursday published final guidance detailing the steps devicemakers must take to obtain a humanitarian use device designation and the agency’s process for evaluating HUD submissions. Under the guidance, HUD designations are available for devices intended to treat or diagnose a condition that affects fewer than 4,000 Americans each year.
Devices & Diagnostics Letter
Devices & Diagnostics Letter
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