中山 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

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.

深圳市思博达管理咨询有限公司是一家从事医疗器械国际咨询的专业性咨询机构。提供各个国家或地区医疗器械注册认证，包括中国NMPA、美国FDA、510(K)、欧盟MDR CE认证、加拿大MDL认证、澳洲TGA认证等等、医疗器械质量体系审查，如中国医疗器械GMP（包括试剂类）、美国QSR820质量体系场考核、欧盟GMP、日本GMP、巴西GMP、ISO13485等）等多种国际注册及认证的咨询、代理服务；也可为您提供医疗器械风险管理、软件确认、灭菌确认、临床评估、可用性确认等专题培训服务。