Inclusion of Demographic-Specific Information in Studies Supporting US Food & Drug Administration Approval of High-Risk Medical Devices.
Level V
Where this comes from
- Record sourced from PubMed, PMID 28738116.
- Also identified by DOI 10.1001/jamainternmed.2017.3148 and PMC identifier 5818834.
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Abstract
This analysis characterizes the studies used to support US Food & Drug Administration 2015 premarket approval of devices, particularly findings of device safety and effectiveness for women, the elderly, and minorities.
Medical subject headings
- Demography
- Device Approval
- United States Food and Drug Administration