Nonconcurrent Control Use in FDA Approval of High-Risk Medical Devices
This cross-sectional study of high-risk therapeutic medical device approvals by the FDA over the past 5 years found that most approvals were based on analyses using nonconcurrent controls with limited justification and clinically relevant details, potentially creating uncertainty for patients, clinicians, and payers regarding the evidence establishing device safety and effectiveness.
Authors
- Sanket S. Dhruva (ORCID: https://orcid.org/0000-0003-0674-2032)
- Vinay K. Rathi (ORCID: https://orcid.org/0000-0002-9763-9075)
- Hollin R.L. Hakimian
- Joseph S. Ross (ORCID: https://orcid.org/0000-0002-9218-3320)
- Kushal T. Kadakia (ORCID: https://orcid.org/0000-0002-9539-7682)
- Maryam Mooghali (ORCID: https://orcid.org/0000-0001-9347-494X)
Institutions
- Harvard University (US)
- University of California, San Francisco (US)
- The Ohio State University Wexner Medical Center (US)
- Yale University (US)
- Yale New Haven Health System (US)
- San Francisco VA Health Care System (US)
Publication Details
- Journal
- JAMA Network Open
- Published
- 2025-04-22
- DOI
- https://doi.org/10.1001/jamanetworkopen.2025.6230
- Citations
- 3
- Primary Topic
- Health Systems, Economic Evaluations, Quality of Life
- Type
- article
- Field-Weighted Citation Impact
- 9.39
Funders
- U.S. Department of Veterans Affairs
- Yale University
- Biogen
- Arnold Ventures
- National Institutes of Health
- Agency for Healthcare Research and Quality
- National Heart, Lung, and Blood Institute