Regulatory landscape of accelerated approval pathways for medical devices in the United States and the European Union.

Abstract

The landscape of medical device regulation is rapidly evolving, driven by innovations and the need to bring these technologies to patients more efficiently. This review provides a comprehensive analysis of the accelerated access pathways for medical devices in the United States (US) and the European Union (EU), focusing on the Breakthrough Devices Program (BDP) in the US and the evolving regulatory framework within the EU. Analysis of Food and Drug Administration (FDA) data reveals that from 201