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類別: CLASSIFICATION

FDA產品代碼

FDA分配的用於按類型分類醫療器材的三字母代碼。產品代碼決定審查委員會、分類和法規要求。FDA系統中有超過6,000個產品代碼。

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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相關術語

510(k)許可等同器材II類醫療器材