FDA Authorization of Therapeutic Devices Under the Breakthrough Devices Program
This study found that most therapeutic breakthrough-designated devices are novel and reviewed by the FDA before statutory target timeframes. However, uncertainty about benefits and risks for some devices raises questions whether BDP is consistently fulfilling program objectives to improve public health.
Authors
- Sanket S. Dhruva (ORCID: https://orcid.org/0000-0003-0674-2032)
- Vinay K. Rathi (ORCID: https://orcid.org/0000-0002-9763-9075)
- Reshma Ramachandran (ORCID: https://orcid.org/0000-0003-3845-3606)
- James L. Johnston (ORCID: https://orcid.org/0000-0002-1359-2485)
- James Burke (ORCID: https://orcid.org/0000-0002-2296-1588)
- Joseph S. Ross (ORCID: https://orcid.org/0000-0002-9218-3320)
- Kushal T. Kadakia (ORCID: https://orcid.org/0000-0002-9539-7682)
- Harlan M. Krumholz
Institutions
- Brigham and Women's Hospital (US)
- San Francisco VA Medical Center (US)
- Yale New Haven Hospital (US)
- Harvard University (US)
- University of California, San Francisco (US)
- Yale University (US)
- Yale New Haven Health System (US)
- The Ohio State University (US)
Publication Details
- Journal
- JAMA Internal Medicine
- Published
- 2025-06-30
- DOI
- https://doi.org/10.1001/jamainternmed.2025.2235
- Citations
- 7
- Primary Topic
- Biomedical Ethics and Regulation
- Type
- article
- Field-Weighted Citation Impact
- 8.15