Assessment of Clinical Trial Evidence for High-Risk Cardiovascular Devices Approved Under the Food and Drug Administration Priority Review Program.
Where this comes from
- Record sourced from PubMed, PMID 30178044.
- Also identified by DOI 10.1001/jamainternmed.2018.3649 and PMC identifier 6584255.
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Abstract
This study uses publicly available FDA summaries to analyze the quality of evidence in pivotal studies that support cardiovascular premarket device approval under FDA priority review from 2007 to 2017.
Medical subject headings
- Cardiovascular Diseases
- Clinical Trials as Topic
- Device Approval
- United States Food and Drug Administration