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類別: REGULATORY PATHWAYS

器材列表

製造商向FDA列出其醫療器材的要求，提供其生產或加工的每個器材的資訊。根據21 CFR第807部分與機構註冊一起要求。

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

Device listing is the FDA requirement to identify devices an establishment is involved with, complementary to establishment registration.

PROCESS / STEPS

  1. List each device proprietary name/product code as required.
  2. Keep listings current after ownership or device changes.
  3. Coordinate with UDI/GUDID data where applicable.

EXAMPLES

  • Contract manufacturers and specification developers may have distinct listing obligations.

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SOURCES

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相關術語

機構註冊FDA產品代碼