KATEGORIE: REGULATORY PATHWAYS

Special 510(k)

Ein vereinfachtes 510(k)-Verfahren für Gerätemodifikationen mit 30-Tage-Prüfung statt 90 Tagen.

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

A Special 510(k) is an FDA pathway for certain device modifications by the same manufacturer relying on design control documentation rather than a full Traditional 510(k), when criteria are met.

PROCESS / STEPS

Confirm eligibility vs Traditional/Abbreviated 510(k).
Document design controls and risk analysis for the change.
Submit Special 510(k) package with clear change description.
Update labeling/production after clearance.

EXAMPLES

A well-controlled material supplier change may qualify when performance is unchanged and design controls are robust.

RELATED GUIDES & TOOLS

SOURCES

FDA 510(k) program ↗

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