Postmarket Surveillance of Medical Devices: A Comparison of Strategies in the US, EU, Japan, and China: e1001519
[...]called "522 studies" (named in reference to the relevant legislation) for select devices (including those medium- or lower-risk devices cleared through the 510(k) pathway based on risk or other criteria) may also be required [11].\n Yet this may reflect a strength of this approach, as...
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Veröffentlicht in: | PLoS medicine 2013-09, Vol.10 (9) |
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Hauptverfasser: | , , , |
Format: | Artikel |
Sprache: | eng |
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Zusammenfassung: | [...]called "522 studies" (named in reference to the relevant legislation) for select devices (including those medium- or lower-risk devices cleared through the 510(k) pathway based on risk or other criteria) may also be required [11].\n Yet this may reflect a strength of this approach, as manufacturers faced with a strict deadline with meaningful consequences are strongly motivated to address post-market concerns well in advance of the re-examination. [...]the systems we reviewed strikingly different balance between central and regional control. |
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ISSN: | 1549-1277 1549-1676 |
DOI: | 10.1371/journal.pmed.1001519 |