美国医疗器械FDA申报产品与对比产品实质等同判定的依据

FDA will determine that a device is substantially equivalent to a predicate device using the following criteria:

FDA判定申报产品与对比产品实质等同的依据有以下

(1) The device has the same intended use as the predicate device; and

申报产品与对比产品有相同的预期用途。

(2) The device:

(i) Has the same technological characteristics as the predicate device; or

申报产品与对比产品有相同的预的技术参数或

(ii)(A) Has different technological characteristics, such as a significant change in the materials, design, energy source, or other features of the device from those of the predicate device;

与对比产品有不同的预的技术参数，如材料，设计、能量来源或其它特征

(B) The data submitted establishes that the device is substantially equivalent to the predicate device and contains information, including clinical data if deemed necessary by the Commissioner, that demonstrates that the device is as safe and as effective as a legally marketed device; and

提交的数据确定该器械实质上等同于对比器械，并包含信息，包括临床数据(如果专员认为必要的话)，证明该器械与合法上市的器械一样安全有效;和

(C) Does not raise different questions of safety and effectiveness than the predicate device.

不会引起与对比产品任何与安全性和有效性的问题

需要FDA 510（K）注册,请联系深圳思博达彭先生 136手机2238号码0915.

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