510K申报 510K Submission

 

"510(k)" – 又称上市前通知(PMN),根据食品、药品和化妆品(FD&C)行动委员会和21 CFR 807的510(k)规章,任何想在美国出售医疗器械的单位都要求在器械上市之前至少90天递交510(k)申请。510(k)文件是向FDA递交的上市前申请文件,目的是证明申请上市的器械与不受上市前批准(PMA)影响的合法上市器械同样安全有效,即为等价器械(substantially equivalent)。申请者必须把申请上市的器械与现在美国市场上一种或多种相似器械对比,得出并且支持等价器械的结论。

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Medical device companies that want to market their products in US can submit 510(k) Premarket Notification to demonstrate that the new product is substantially equivalent to a "predicate device". Once FDA determines that the new product is at least safe and effective as the predicate device, the new product can be marketed in US

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