Humanitarian Device Exemption

Preferred Label : Humanitarian Device Exemption;

NCIt synonyms : HDE;

NCIt related terms : Humanitarian Device Exemption (HDE);

NCIt definition : 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.;

Alternative definition : PQCMC: PQCMC data submitted for an HDE application.;

Details

Origin ID

C80440;

UMLS CUI

C2718015;

Automatic exact mappings (from CISMeF team)
- compassionate use trials [MeSH Descriptor]
Currated CISMeF NLP mapping
- humanitarian device exemption [MeSH concept]
Semantic type(s)
- Medical Device [UMLS semantic type]
UMLS correspondences (same concept)
- humanitarian device exemption [MeSH concept]
concept_is_in_subset
- FDA CDRH GUDID Terminology [NCIt concept]
- FDA Pharmaceutical Quality/CMC Terminology [NCIt concept]
- FDA Structured Product Labeling Terminology [NCIt concept]
- PQ/CMC Stability Study Reason Terminology [NCIt concept]
- SPL Marketing Category Terminology [NCIt concept]

Keyword's position in hierarchy(ies) :

You can consult :

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