CATEGORY: REGULATORY PATHWAYS

Device Listing

The requirement for manufacturers to list their medical devices with the FDA, providing information about each device they make or process. Required under 21 CFR Part 807 alongside establishment registration.

Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · 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

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

EXAMPLES

Contract manufacturers and specification developers may have distinct listing obligations.

RELATED GUIDES & TOOLS

Establishment registration →
GUDID →

SOURCES

FDA Registration & Listing ↗

Track regulatory signals related to Device Listing across 27 authorities in real time.

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