P116: Regulatory Landscape of Accelerated Approval Pathways for Medical Devices in the US and EU
Poster Presenter
Tanvi A Gupte
Student
University of Maryland United States
Objectives
The objective of this study is to analyze and compare accelerated access pathways for medical devices in the United States and European Union, examining their impact on innovation, funding, patient safety, and global harmonization efforts.
Method
This study analyzed current regulatory frameworks, policies, and literature. We examined data and statistics from regulatory bodies, industry reports, publications, Guidances, and official government websites, compiling findings to evaluate the effectiveness and challenges of these pathways.
Results
The study highlights the complex regulatory landscape and challenges in accelerated access pathways in the US and EU. As of September 2024, the FDA's Breakthrough Devices Program (BDP) has granted 1,041 designations, with 128 (12.3%) receiving marketing authorization. The total number of devices receiving marketing authorization has increased significantly in the US, from just one device each in 2016 and 2017 to 32 devices in 2024. In the EU, implementation of the MDR and Health Technology Assessment Regulation (HTAR) aims to streamline device development and patient access. The number of EU Notified Bodies designated under the Medical Devices Regulation (MDR) has increased from about 20 in 2021 to 50 in 2024. Challenges exist in harmonizing processes across EU countries and balancing centralized assessment with national decision-making. One major concern with accelerated pathways is the reliance on limited clinical data, which necessitates robust post-market surveillance. Global regulatory agencies face resource constraints in monitoring real-world device performance.
Conclusion
Accelerated access pathways play a critical role in expediting market entry for innovative medical devices addressing unmet needs. However, significant challenges persist. Regulatory bodies must work closely with industry stakeholders to refine accelerated pathways by standardizing evidence generation, enhancing post-market surveillance capabilities, and addressing funding and coverage challenges. By implementing strategies of harmonization, reliance, and collaboration, the global medical device community can work towards a more unified regulatory landscape with reduced duplication of efforts. These improvements will ensure that accelerated approvals translate into timely patient access to safe, effective, and innovative medical technologies worldwide.
