TERMIUM Plus®

The Government of Canada’s terminology and linguistic data bank.

PRE-MARKET APPROVAL APPLICATION [1 record]

Record 1 2014-01-07

English

Subject field(s)
  • Commercial Law
  • Marketing
  • General Medicine, Hygiene and Health
DEF

An application made by the manufacturer to the Food and Drug Administration (FDA) for approval to market a medical product in the United States.

OBS

This application includes the pertinent information documenting the safety and effectiveness of the product.

OBS

premarket approval application; PMA: term, abbreviation and definition standardized by the Health Technology Assessment (HTA) Glossary English Editorial Board and the Translation Bureau.

Key term(s)
  • pre-market approval application
  • pre-marketing approval application

French

Domaine(s)
  • Droit commercial
  • Commercialisation
  • Médecine générale, hygiène et santé
DEF

Demande d’approbation de la commercialisation d’un produit médical aux États-Unis présentée par le fabricant à la Food and Drug Administration (FDA).

OBS

demande d'autorisation de mise en marché; demande d'autorisation de mise sur le marché; demande d'approbation préalable à la mise en marché : termes et définition normalisés par l'Institut national d'excellence en santé et en services sociaux (INESSS) et le Bureau de la traduction.

Spanish

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