Clinical Evidence Supporting US Food and Drug Administration Clearance of Novel Therapeutic Devices via the De Novo Pathway Between 2011 and 2019.
cross_sectional · Level IV
Where this comes from
- Record sourced from PubMed, PMID 33044513.
- Also identified by DOI 10.1001/jamainternmed.2020.3214 and PMC identifier 7551221.
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Abstract
This cross-sectional study characterizes the premarket clinical evidence supporting clearance of moderate-risk novel therapeutic medical devices by the US Food and Drug Administration.
Medical subject headings
- Device Approval
- Equipment Safety
- Equipment and Supplies
- Product Surveillance, Postmarketing