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关注：1
2013-05-23 12:21
求翻译：Please note that FDA does not perform 510(k) pre-clearance facility inspections. The submitter may market the device immediately after 510(k) clearance is granted. The manufacturer should be prepared for an FDA quality system (21 CFR 820) inspection at any time after 510(k) clearance.是什么意思？ 待解决
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- 离问题结束还有
Please note that FDA does not perform 510(k) pre-clearance facility inspections. The submitter may market the device immediately after 510(k) clearance is granted. The manufacturer should be prepared for an FDA quality system (21 CFR 820) inspection at any time after 510(k) clearance.
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2013-05-23 12:21:38
请注意，FDA不执行510（K）的预清关设施检查。提交者可能市场的设备，立即被授予后，510（k）许可。制造商应准备FDA的质量体系（21 CFR 820）510（k）许可后，在任何时间的检验。
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2013-05-23 12:23:18
请注意,fda并不执行510(k)预先清关设施检查。 市场的“提交人”可能的设备后立即510(k)的间隙。 制造商应该准备一个fda质量系统(21cfr820)检查后的任何时间在510(k)间隙。
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2013-05-23 12:24:58
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2013-05-23 12:26:38
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2013-05-23 12:28:18
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