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...
Saved in:
| Main Authors: | , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2025-05-01
|
| Series: | Frontiers in Medical Technology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fmedt.2025.1586070/full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849321454366097408 |
|---|---|
| author | Tanvi Gupte Tushar Nitave Tushar Nitave Jogarao Gobburu |
| author_facet | Tanvi Gupte Tushar Nitave Tushar Nitave Jogarao Gobburu |
| author_sort | Tanvi Gupte |
| collection | DOAJ |
| description | 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 2015 to 2024, only 12.3% of the 1,041 BDP-designated devices received marketing authorization, with mean decision times of 152, 262, and 230 days for 510(k), de novo, and PMA pathways respectively—significantly faster than standard approvals for de novo (338 days) and PMA (399 days). In the EU, where no specific accelerated pathway exists, the recently implemented Medical Device Regulation and Health Technology Assessment Regulation aim to harmonize approval processes, with joint clinical assessments beginning in 2026. The analysis explores the interplay between regulatory approval, funding mechanisms, and coverage policies that collectively determine the accessibility of medical devices. The unique challenges associated with emerging technologies and the implementation of accelerated pathways are also discussed. We recommend global regulatory convergence through harmonized standards, mutual recognition agreements, and unified post-market surveillance systems to balance innovation with patient safety. |
| format | Article |
| id | doaj-art-afe19fc9d63a4032bdfdd91f1071d157 |
| institution | Kabale University |
| issn | 2673-3129 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Medical Technology |
| spelling | doaj-art-afe19fc9d63a4032bdfdd91f1071d1572025-08-20T03:49:45ZengFrontiers Media S.A.Frontiers in Medical Technology2673-31292025-05-01710.3389/fmedt.2025.15860701586070Regulatory landscape of accelerated approval pathways for medical devices in the United States and the European UnionTanvi Gupte0Tushar Nitave1Tushar Nitave2Jogarao Gobburu3Center for Translational Medicine, University of Maryland School of Pharmacy, Baltimore, MD, United StatesCenter for Translational Medicine, University of Maryland School of Pharmacy, Baltimore, MD, United StatesDepartment of Translational Medicine, Vivpro.ai, Jersey City, NJ, United StatesCenter for Translational Medicine, University of Maryland School of Pharmacy, Baltimore, MD, United StatesThe 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 2015 to 2024, only 12.3% of the 1,041 BDP-designated devices received marketing authorization, with mean decision times of 152, 262, and 230 days for 510(k), de novo, and PMA pathways respectively—significantly faster than standard approvals for de novo (338 days) and PMA (399 days). In the EU, where no specific accelerated pathway exists, the recently implemented Medical Device Regulation and Health Technology Assessment Regulation aim to harmonize approval processes, with joint clinical assessments beginning in 2026. The analysis explores the interplay between regulatory approval, funding mechanisms, and coverage policies that collectively determine the accessibility of medical devices. The unique challenges associated with emerging technologies and the implementation of accelerated pathways are also discussed. We recommend global regulatory convergence through harmonized standards, mutual recognition agreements, and unified post-market surveillance systems to balance innovation with patient safety.https://www.frontiersin.org/articles/10.3389/fmedt.2025.1586070/fullbreakthrough devicesaccelerated approvalmedical devicesharmonizationMedical Device Regulation (MDR)Food and Drug Administration (FDA) |
| spellingShingle | Tanvi Gupte Tushar Nitave Tushar Nitave Jogarao Gobburu Regulatory landscape of accelerated approval pathways for medical devices in the United States and the European Union Frontiers in Medical Technology breakthrough devices accelerated approval medical devices harmonization Medical Device Regulation (MDR) Food and Drug Administration (FDA) |
| title | Regulatory landscape of accelerated approval pathways for medical devices in the United States and the European Union |
| title_full | Regulatory landscape of accelerated approval pathways for medical devices in the United States and the European Union |
| title_fullStr | Regulatory landscape of accelerated approval pathways for medical devices in the United States and the European Union |
| title_full_unstemmed | Regulatory landscape of accelerated approval pathways for medical devices in the United States and the European Union |
| title_short | Regulatory landscape of accelerated approval pathways for medical devices in the United States and the European Union |
| title_sort | regulatory landscape of accelerated approval pathways for medical devices in the united states and the european union |
| topic | breakthrough devices accelerated approval medical devices harmonization Medical Device Regulation (MDR) Food and Drug Administration (FDA) |
| url | https://www.frontiersin.org/articles/10.3389/fmedt.2025.1586070/full |
| work_keys_str_mv | AT tanvigupte regulatorylandscapeofacceleratedapprovalpathwaysformedicaldevicesintheunitedstatesandtheeuropeanunion AT tusharnitave regulatorylandscapeofacceleratedapprovalpathwaysformedicaldevicesintheunitedstatesandtheeuropeanunion AT tusharnitave regulatorylandscapeofacceleratedapprovalpathwaysformedicaldevicesintheunitedstatesandtheeuropeanunion AT jogaraogobburu regulatorylandscapeofacceleratedapprovalpathwaysformedicaldevicesintheunitedstatesandtheeuropeanunion |