美国医疗器械FDA 如何判定申报产品与对比产品实质等同，FDA申报产品与对比产品实质等同判定的依据、

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 e 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 e 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 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.