US Food and Drug Administration Approval of High-risk Cardiovascular Devices for Use in Children and Adolescents, 1977-2021.
retrospective_cohort · Level III
Where this comes from
- Record sourced from PubMed, PMID 35943478.
- Also identified by DOI 10.1001/jama.2022.10041 and PMC identifier 9364120.
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Abstract
This study uses data from US Food and Drug Administration (FDA) databases to quantify approval of high-risk cardiovascular devices for use in pediatric populations and assess the clinical evidence supporting the approvals.
Medical subject headings
- Cardiovascular System
- Device Approval
- United States Food and Drug Administration