Describing Inconsistencies in Pediatric Labeling of Medical Devices
In this cross-sectional analysis of devices included the 2008 to 2017 Reports to Congress, most high-risk devices were not evaluated or specifically indicated for children younger than 18 years. This poses substantial problems for clinical use, reimbursement, research, and policy evaluation. To address this gap, the FDA should establish pediatric labeling requirements that consider age and other relevant factors.
Authors
- Juan Espinoza (ORCID: https://orcid.org/0000-0003-0513-588X)
- Payal Shah (ORCID: https://orcid.org/0000-0001-5211-6169)
- Benjamin Scott Glicksberg (ORCID: https://orcid.org/0000-0003-4515-8090)
- Melissa A. Bent (ORCID: https://orcid.org/0000-0002-6656-3397)
- Grzegorz Zapotoczny (ORCID: https://orcid.org/0000-0003-2036-2992)
- Yaniv Bar‐Cohen (ORCID: https://orcid.org/0000-0002-6415-3685)
- Florence T. Bourgeois (ORCID: https://orcid.org/0000-0001-7798-4560)
- Alexis Snitman
Institutions
- Northwestern University (US)
- University of Southern California (US)
- Lurie Children's Hospital (US)
- Children's Hospital of Los Angeles (US)
- Harvard University (US)
- Icahn School of Medicine at Mount Sinai (US)
Publication Details
- Journal
- JAMA Network Open
- Published
- 2025-12-04
- DOI
- https://doi.org/10.1001/jamanetworkopen.2025.46517
- Citations
- 3
- Primary Topic
- Pharmaceutical studies and practices
- Type
- article
- Field-Weighted Citation Impact
- 10.48
Funders
- U.S. Department of Health and Human Services
- Sanofi
- Dexcom