Pesquisa
Descritor em português: Aprovação de Equipamentos
Descritor em inglês: Device Approval
Descritor em espanhol: Aprobación de Recursos
Descritor autorización de dispositivos
Termo(s) alternativo(s) autorización de dispositivos nuevos
autorización de nuevos dispositivos
proceso de autorización de dispositivos
Nota de escopo: Proceso por el cual un aparato recibe la aprobación por parte de una agencia reguladora gubernamental. Incluye cualquier prueba clínica o preclínica requerida, la revisión, presentación y evaluación de las solicitudes y de los resultados de las pruebas y la vigilancia después de su introducción en el mercado. No se limita a una única agencia como pudiera ser la FDA en el caso de los EE. UU.
Descritor em francês: Agrément de dispositif
Termo(s) alternativo(s): Approval Process, Device
Approval Processes, Device
Approval, Device
Approval, New Device
Approvals, Device
Approvals, New Device
Device Approval Process
Device Approval Processes
Device Approval, New
Device Approvals
Device Approvals, New
Food and Drug Administration Device Approval
Food and Drug Administration Device Approval Process
New Device Approval
New Device Approval Process
New Device Approvals
Process, Device Approval
Processes, Device Approval
Código(s) hierárquico(s): E05.337.275
N06.850.210.275
VS2.006.004
Identificador Único RDF: https://id.nlm.nih.gov/mesh/D018795
Nota de escopo: Process that is gone through in order for a device to receive approval by a government regulatory agency. This includes any required preclinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance. It is not restricted to FDA.
Nota de indexação: by a govt regulatory agency, not restricted to FDA
Qualificadores permitidos: LJ legislation & jurisprudence
ST standards
Indexação Anterior: Consumer Product Safety (1966-1994)
Nota MeSH pública: 95
Nota histórica: 95
Identificador DeCS: 32291
ID do descritor: D018795
Classificação da NLM: WA 289
Documentos indexados na Biblioteca Virtual em Saúde (BVS): Clique aqui para acessar os documentos da BVS
Data de estabelecimento: 01/01/1995
Data de entrada: 01/06/1994
Data de revisão: 08/07/2008
Device Approval - Conceito preferido
Identificador do conceito M0028140
Nota de escopo Process that is gone through in order for a device to receive approval by a government regulatory agency. This includes any required preclinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance. It is not restricted to FDA.
Termo preferido Device Approval
Termo(s) alternativo(s) Approval Process, Device
Approval Processes, Device
Approval, Device
Approvals, Device
Device Approval Process
Device Approval Processes
Device Approvals
Process, Device Approval
Processes, Device Approval
Food and Drug Administration Device Approval Process - Mais específico
Identificador do conceito M0028137
Termo preferido Food and Drug Administration Device Approval Process
New Device Approval - Mais específico
Identificador do conceito M0028139
Termo preferido New Device Approval
Termo(s) alternativo(s) Approval, New Device
Approvals, New Device
Device Approval, New
Device Approvals, New
New Device Approvals
Food and Drug Administration Device Approval - Mais específico
Identificador do conceito M0028136
Termo preferido Food and Drug Administration Device Approval
New Device Approval Process - Mais específico
Identificador do conceito M0028138
Termo preferido New Device Approval Process



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