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CATEGORY: REGULATORY PATHWAYS
Establishment Registration
The requirement for manufacturers, distributors, and importers of medical devices to register their facilities with the FDA annually under 21 CFR Part 807. Registration does not imply FDA approval or clearance.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · 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 Establishment Registration across 27 authorities in real time.
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