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

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...

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Autors principals:	Tanvi Gupte, Tushar Nitave, Jogarao Gobburu
Format:	Artigo
Idioma:	Inglês
Publicat:	Frontiers Media S.A. 2025-05-01
Col·lecció:	Frontiers in Medical Technology
Matèries:	breakthrough devices accelerated approval medical devices harmonization Medical Device Regulation (MDR) Food and Drug Administration (FDA)
Accés en línia:	https://www.frontiersin.org/articles/10.3389/fmedt.2025.1586070/full
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