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Humanitarian Device Exemption
Definition 1
A premarket submission to FDA for a device intended to benefit patients by treating or diagnosing a condition affecting fewer than 4,000 individuals in the United States per year. An HDE is similar in form and content to a premarket approval (PMA) but is exempt from the effectiveness requirements of a PMA. (NCI Thesaurus)
Definition 2
Stability data submitted for an HDE application. (Food and Drug Administration)
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