CATEGORY: REGULATORY PATHWAYS

Compassionate Use / Expanded Access

A pathway allowing patients access to investigational medical devices outside of clinical trials when no comparable approved device exists and the patient has a serious condition. In the US, managed through FDA Emergency Use Authorization or Expanded Access.

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

Track regulatory signals related to Compassionate Use / Expanded Access across 27 authorities in real time.

START FREE →