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The regulatory ancestral network of surgical meshes
BACKGROUND: All surgical meshes entering the U.S. market have been cleared for clinical use by the 510(k) process of the Food and Drug Administration (FDA), in which devices simply require proof of “substantial equivalence” to predicate devices, without the need for clinical trials. However, recalle...
| Autores principales: | , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Public Library of Science
2018
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6007828/ https://www.ncbi.nlm.nih.gov/pubmed/29920525 http://dx.doi.org/10.1371/journal.pone.0197883 |