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Pivotal trials of orthopedic surgical devices in the United States: predominance of two-arm non-inferiority designs
BACKGROUND: The United States Food and Drug Administration (FDA) reviews class III orthopedic devices submitted for premarket approval with pivotal clinical trials. The purpose of this study was to determine the types of orthopedic devices reviewed, the design of their pivotal clinical trials, and t...
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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BioMed Central
2017
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5525262/ https://www.ncbi.nlm.nih.gov/pubmed/28738891 http://dx.doi.org/10.1186/s13063-017-2032-2 |