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CATÉGORIE: REGULATORY PATHWAYS
Usage compassionnel / Accès élargi
Une voie permettant aux patients d'accéder à des dispositifs expérimentaux en dehors des essais cliniques.
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
Track regulatory signals related to Usage compassionnel / Accès élargi across 27 authorities in real time.
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