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类别: REGULATORY PATHWAYS
机构注册
制造商、分销商和进口商每年需根据21 CFR第807部分向FDA注册其设施。注册并不意味着FDA批准或许可。
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
Most US device establishments must register with FDA and list devices annually; foreign establishments typically designate a US agent.
PROCESS / STEPS
- Determine establishment type (manufacturer, spec developer, etc.).
- Register and list devices in FURLS.
- Pay annual fees; update within required windows after changes.
EXAMPLES
- Failure to register/list can make devices misbranded even if 510(k)-cleared.
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SOURCES
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