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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| container_title | PLoS medicine |
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| creator | Kramer, Daniel B Tan, Yongtian T Sato, Chiaki Kesselheim, Aaron S |
| description | [...]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. |
| doi_str_mv | 10.1371/journal.pmed.1001519 |
| format | Article |
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| ispartof | PLoS medicine, 2013-09, Vol.10 (9) |
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| language | eng |
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| source | DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central; Public Library of Science (PLoS) |
| subjects | Disease FDA approval Manufacturers Medical device industry Medical equipment Medical technology Prostheses Technological change Transplants & implants |
| title | Postmarket Surveillance of Medical Devices: A Comparison of Strategies in the US, EU, Japan, and China: e1001519 |
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