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类别: CLASSIFICATION

FDA产品代码

FDA分配的用于按类型分类医疗器械的三字母代码。产品代码决定审查委员会、分类和法规要求。FDA系统中有超过6,000个产品代码。

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

  1. Search the product classification database by keywords.
  2. Confirm three-letter product code and submission type.
  3. Use the code for predicate search and testing planning.
  4. 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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相关术语

510(k)许可等同器械II类医疗器械