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

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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Bibliographic Details
Main Authors: Tanvi Gupte, Tushar Nitave, Jogarao Gobburu
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-05-01
Series:Frontiers in Medical Technology
Subjects:
breakthrough devices
accelerated approval
medical devices
harmonization
Medical Device Regulation (MDR)
Food and Drug Administration (FDA)
Online Access:https://www.frontiersin.org/articles/10.3389/fmedt.2025.1586070/full
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