Eine umfassende Übersicht über reale-world-Evidenz in der Zulassung von medizinischen Geräten in den Vereinigten Staaten.

Zusammenfassung

Despite the U.S. Food and Drug Administration (FDA)'s recognition of the value of real-world evidence (RWE) in the evaluation of medical devices, there is a lack of consensus among RWE stakeholders regarding the FDA's specific evidentiary requirements. This paper reviews the publicly accessible FDA approval documents from January 2020 to July 2024 and describes the intended purpose of RWE incorporated into medical device approvals, i.e. to support claims of safety and/or effectiveness and its im