The regulatory ancestral network of surgical meshes

@article{Zargar2018TheRA,
  title={The regulatory ancestral network of surgical meshes},
  author={Nasim Zargar and Andrew J. Carr},
  journal={PLoS ONE},
  year={2018},
  volume={13}
}
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, recalled meshes associated with adverse effects may, indirectly, continue to serve as predicates for new devices raising concerns over the safety of the 510(k) route. Methodology Here we assess the potential… 
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