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The Government of Canada’s terminology and linguistic data bank.
INVESTIGATIONAL DEVICE EXEMPTION [2 records]
Record 1 - internal organization data 2014-01-22
Record 1, English
Record 1, Subject field(s)
- Pharmacology
- Food Industries
Record 1, Main entry term, English
- investigational device exemption
1, record 1, English, investigational%20device%20exemption
correct, standardized
Record 1, Abbreviations, English
- IDE 2, record 1, English, IDE
correct, standardized
Record 1, Synonyms, English
Record 1, Textual support, English
Record number: 1, Textual support number: 1 DEF
A regulatory process and categorization whereby the United States Food and Drug Administration (FDA) authorizes specified use of an unapproved device in controlled settings for collecting data on the device’s safety and theoretical or practical effectiveness. 1, record 1, English, - investigational%20device%20exemption
Record number: 1, Textual support number: 1 OBS
The data thus collected may be used subsequently in a premarketing approval application. 1, record 1, English, - investigational%20device%20exemption
Record number: 1, Textual support number: 2 OBS
investigational device exemption; IDE: term, abbreviation and definition standardized by the Health Technology Assessment (HTA) Glossary English Editorial Board and the Translation Bureau. 3, record 1, English, - investigational%20device%20exemption
Record 1, French
Record 1, Domaine(s)
- Pharmacologie
- Industrie de l'alimentation
Record 1, Main entry term, French
- exemption des dispositifs de recherche
1, record 1, French, exemption%20des%20dispositifs%20de%20recherche
correct, feminine noun, standardized
Record 1, Abbreviations, French
Record 1, Synonyms, French
Record 1, Textual support, French
Record number: 1, Textual support number: 1 DEF
Processus et catégorisation réglementaires par lesquels la Food and Drug Administration (FDA) des États-Unis autorise l’usage spécifique d’un produit non approuvé, dans des milieux contrôlés, à des fins de collecte de données sur son innocuité et son efficacité théorique ou pratique. 1, record 1, French, - exemption%20des%20dispositifs%20de%20recherche
Record number: 1, Textual support number: 1 OBS
Les données ainsi recueillies pourront ensuite être utilisées pour une demande d’autorisation de mise en marché. 1, record 1, French, - exemption%20des%20dispositifs%20de%20recherche
Record number: 1, Textual support number: 2 OBS
exemption des dispositifs de recherche : terme et définition normalisés par l'Institut national d'excellence en santé et en services sociaux (INESSS) et le Bureau de la traduction. 2, record 1, French, - exemption%20des%20dispositifs%20de%20recherche
Record 1, Spanish
Record 1, Textual support, Spanish
Record 2 - internal organization data 1999-09-29
Record 2, English
Record 2, Subject field(s)
- Titles of Documents and Works
- Medical and Surgical Equipment
Record 2, Main entry term, English
- Investigational Device Exemption 1, record 2, English, Investigational%20Device%20Exemption
Record 2, Abbreviations, English
Record 2, Synonyms, English
Record 2, Textual support, English
Record number: 2, Textual support number: 1 OBS
Title of section 1.3 (chapter 3) of the "Quality System Requirements For Medical Devices - Reference Guide For Manufacturers Selling Medical Devices in Europe, Canada and the United States". 1, record 2, English, - Investigational%20Device%20Exemption
Record 2, French
Record 2, Domaine(s)
- Titres de documents et d'œuvres
- Équipement médico-chirurgical
Record 2, Main entry term, French
- Exemption des dispositifs de recherche
1, record 2, French, Exemption%20des%20dispositifs%20de%20recherche
feminine noun
Record 2, Abbreviations, French
Record 2, Synonyms, French
Record 2, Textual support, French
Record number: 2, Textual support number: 1 OBS
Titre de la section 1.3 (chapitre 3) du manuel «Exigences en matière de système qualité pour les dispositifs médicaux - Manuel de référence à l'intention des fabricants qui vendent des dispositifs médicaux en Europe, au Canada et aux États-Unis». 1, record 2, French, - Exemption%20des%20dispositifs%20de%20recherche
Record 2, Spanish
Record 2, Textual support, Spanish
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