Humanitarian Device Exemptions

This data package contains the access to Humanitarian Device Exemption provided by the FDA for Humanitarian Use Device (HUD). Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. A device manufacturer's research and development costs could exceed its market returns for diseases or conditions affecting small patient populations.

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1. Center for Devices and Radiological Health Device Exemptions

The Center for Devices and Radiological Health (CDRH) Humanitarian Device Exemptions dataset includes the list of Humanitarian Device Exemptions delivered by the Food and Drug Administration (FDA). A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.

2. Humanitarian Device Exemption

This dataset includes the list of Humanitarian Device Exemptions delivered by the Food and Drug Administration (FDA). A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. A device manufacturer's research and development costs could exceed its market returns for diseases or conditions affecting small patient populations.

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