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CATÉGORIE: CLASSIFICATION
Code produit FDA
Un code à trois lettres attribué par la FDA pour catégoriser les dispositifs médicaux par type.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.
WHEN IT APPLIES
FDA product codes classify device types and drive regulation numbers, submission types, and guidance applicability.
PROCESS / STEPS
- Search the product classification database by keywords.
- Confirm three-letter product code and submission type.
- Use the code for predicate search and testing planning.
- Monitor competitor clearances under the same code.
EXAMPLES
- OpenFDA and 510(k) databases are commonly filtered by product code for surveillance.
RELATED GUIDES & TOOLS
SOURCES
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