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类别: REGULATORY PATHWAYS

器械列表

制造商向FDA列出其医疗器械的要求，提供其生产或加工的每个器械的信息。根据21 CFR第807部分与机构注册一起要求。

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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相关术语

机构注册FDA产品代码