US Food and Drug Administration-Mandated Postmarketing Studies for High-risk Cardiovascular Devices Approved 2015-2019.
review · Level V
Where this comes from
- Record sourced from PubMed, PMID 35286367.
- Also identified by DOI 10.1001/jamainternmed.2022.0184 and PMC identifier 8922201.
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Abstract
This qualitative study assesses the availability and strength of evidence of postapproval studies for high-risk cardiovascular devices subsequent to the 21st Century Cures Act.
Medical subject headings
- Drug Approval
- Product Surveillance, Postmarketing