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The regulatory ancestral network of surgical meshes

Abstract:
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<...> Expand abstract
Publication status:
Published
Peer review status:
Peer reviewed
Version:
Publisher's version

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Publisher copy:
10.1371/journal.pone.0197883

Authors


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Institution:
University of Oxford
Division:
Medical Sciences Division
Department:
NDORMS
More by this author
Institution:
University of Oxford
Division:
Medical Sciences Division
Department:
NDORMS
Oxford college:
Worcester College
ORCID:
0000-0001-5940-1464
NIHR Oxford Biomedical Research Centre More from this funder
Publisher:
Public Library of Science Publisher's website
Journal:
PLoS ONE Journal website
Volume:
13
Issue:
6
Pages:
Article: e0197883
Publication date:
2018-06-19
Acceptance date:
2018-06-08
DOI:
ISSN:
1932-6203
Pubs id:
pubs:856881
URN:
uri:cd564532-8f15-4acb-9918-2b12428caffa
UUID:
uuid:cd564532-8f15-4acb-9918-2b12428caffa
Local pid:
pubs:856881

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