1. FDA Issues Final Guidance For Humanitarian Device Exemption Program

    FDA Issues Final Guidance For Humanitarian Device Exemption Program

    ' For a device to be eligible for an HDE, the FDA must determine that the device would not be available to a person with a given disease or condition without the HDE approval. Further, the agency must establish that there is no comparable device available to treat or diagnose the disease or condition, other than another device approved under an HDE or IDE.'

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