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)
Hauptverfasser: Kramer, Daniel B, Tan, Yongtian T, Sato, Chiaki, Kesselheim, Aaron S
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.
ISSN:1549-1277
1549-1676
DOI:10.1371/journal.pmed.1001519