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www.fdanews.com/articles/152738-fda-finalizes-guidance-on-device-humanitarian-use-designations

FDA Finalizes Guidance on Device Humanitarian Use Designations

January 29, 2013
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