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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

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Publisher copy:
10.1371/journal.pone.0197883

Authors


More by this author
Institution:
University of Oxford
Division:
Medical Sciences Division
Department:
NDORMS
Role:
Author
More by this author
Institution:
University of Oxford
Division:
MSD
Department:
NDORMS
Oxford college:
Worcester College
Role:
Author
ORCID:
0000-0001-5940-1464
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Name:
NIHR Oxford Biomedical Research Centre
Publisher:
Public Library of Science
Journal:
PLoS ONE More from this journal
Volume:
13
Issue:
6
Article number:
e0197883
Publication date:
2018-06-19
Acceptance date:
2018-06-08
DOI:
ISSN:
1932-6203
Pubs id:
pubs:856881
UUID:
uuid:cd564532-8f15-4acb-9918-2b12428caffa
Local pid:
pubs:856881
Source identifiers:
856881
Deposit date:
2018-06-11

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