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Descriptor English: Device Approval
Descriptor Spanish: Aprobación de Recursos
Descriptor autorización de dispositivos
Entry term(s) autorización de dispositivos nuevos
autorización de nuevos dispositivos
proceso de autorización de dispositivos
Scope note: 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.
Descriptor Portuguese: Aprovação de Equipamentos
Descriptor French: Agrément de dispositif
Entry term(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
Tree number(s): E05.337.275
N06.850.210.275
VS2.006.004
RDF Unique Identifier: https://id.nlm.nih.gov/mesh/D018795
Scope note: 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.
Annotation: by a govt regulatory agency, not restricted to FDA
Allowable Qualifiers: LJ legislation & jurisprudence
ST standards
Previous Indexing: Consumer Product Safety (1966-1994)
Public MeSH Note: 95
History Note: 95
DeCS ID: 32291
Unique ID: D018795
NLM Classification: WA 289
Documents indexed in the Virtual Health Library (VHL): Click here to access the VHL documents
Date Established: 1995/01/01
Date of Entry: 1994/06/01
Revision Date: 2008/07/08
Device Approval - Preferred
Concept UI M0028140
Scope note 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.
Preferred term Device Approval
Entry term(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 - Narrower
Concept UI M0028137
Preferred term Food and Drug Administration Device Approval Process
New Device Approval - Narrower
Concept UI M0028139
Preferred term New Device Approval
Entry term(s) Approval, New Device
Approvals, New Device
Device Approval, New
Device Approvals, New
New Device Approvals
Food and Drug Administration Device Approval - Narrower
Concept UI M0028136
Preferred term Food and Drug Administration Device Approval
New Device Approval Process - Narrower
Concept UI M0028138
Preferred term New Device Approval Process



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