KATEGORIE: REGULATORY PATHWAYS

Compassionate Use / Erweiterter Zugang

Ein Weg, der Patienten Zugang zu Prüfprodukten außerhalb klinischer Studien ermöglicht.

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

Compassionate use / expanded access pathways allow patients with serious conditions access to investigational devices outside clinical trials when criteria are met (FDA expanded access; similar national mechanisms elsewhere).

PROCESS / STEPS

Confirm patient eligibility and lack of satisfactory alternatives.
Obtain required FDA/IRB (or national) authorizations and informed consent.
Manufacture and label under investigational controls.
Report outcomes and adverse events as required; do not use as a marketing substitute.

EXAMPLES

FDA expanded access for devices may proceed via IDE supplemental pathways for individual patients or intermediate groups.

RELATED GUIDES & TOOLS

SOURCES

FDA Expanded Access for medical devices ↗

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