← 所有術語
類別: REGULATORY PATHWAYS
機構註冊
製造商、分銷商和進口商每年需根據21 CFR第807部分向FDA註冊其設施。註冊並不意味著FDA批准或許可。
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.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to 機構註冊 across 27 authorities in real time.
START FREE →