About: Humanitarian Device Exemption

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An Entity of Type : owl:Class, within Data Space : linked.opendata.cz associated with source document(s)

Attributes	Values
rdf:type	Class
rdfs:label	Humanitarian Device Exemption
rdfs:subClassOf	Premarket Approval Application
Concept_In_Subset	Structured Product Labeling Marketing Category Terminology Stability Study Data File Reason Terminology
Semantic_Type	Intellectual Product
Preferred_Name	Humanitarian Device Exemption
UMLS_CUI	C2718015
FDA_Table	Marketing Category (C-DRG-0935)
Contributing_Source	FDA
ALT_DEFINITION	Stability data submitted for an HDE application.FDAStability
Legacy_Concept_Name	Humanitarian_Device_Exemption
FULL_SYN	Humanitarian Device Exemption (HDE)PTFDA HDEABFDA HDEABNCI HUMANITARIAN DEVICE EXEMPTIONPTFDA Humanitarian Device ExemptionPTNCI
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.NCI
code	C80440
http://linked.open...y/mesh/hasConcept	http://linked.opendata.cz/resource/mesh/concept/M0536574

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