Health / Medical Topics |
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)
YOU MAY ALSO LIKE

Viruses which routinely infect humans

Catalog of genes expressed in cells at various stages of tumor development. hGTI is part of CGAP. (Bypass Budget)

An oral rinse solution containing a strain of the bacteria Lactococcus lactis (L. lactis) genetically modified to express human Trefoil Factor 1…

A partially purified preparation isolated from the thymus and containing several peptides. Human Thymosin-Fraction 5 (TF-5) possesses immunopotentiating properties and can correct…

A type of virus that infects T cells (a type of white blood cell) and can cause leukemia and lymphoma. Human T-cell…

A type of virus that infects T cells (a type of white blood cell) and can cause leukemia and lymphoma. Human T-cell…
