1
关注
1149
浏览

Do we need the control groupin the animal experiment?

您还未登录!暂时最多只可查看 1 条回答

登录! 还没有账号?去注册

ku1314520 一阶会员 用户来自于: 广东省深圳市
2023-09-17 22:42

The animal experiment mainly provides evidence for thefinalization of product design, provides the evidence for the medicaldevice to enter the clinical research stage, and realizes the protectionto the clinical subject.
If new mechanism,working principle, structure design,application methods (such as operation), performance improving isadopted, the administrative counterparts should focus on the relevantrisk assessment of innovation point, and make verification and/or validation on the efficacy of risk control methods, therefore toconform whether to carry on the animal experiment referring to therisk management principles.
For example,carbon dioxide laser therapy equipment adoptsnew structural design to improve performance, or new functions(such as lattice scanning) for new clinical purposes. When benchperformance test research is not sufficient to determine the basicsafety of the product, animal experiments should be carried outbefore clinical trials.

Animal experiments do not have to make control group.

关于作者

问题动态

发布时间
2023-09-17 22:42
更新时间
2023-09-17 22:42
关注人数
1 人关注

推荐内容

牙种植体与基台的连接方式是否属于产品结构及组成应规定的内容?
中频治疗仪产品中,通过按键控制强度、温度、时间等参数,通过液晶显示屏显示参数的简单的控制程序是否算是软件?如果是软件应当算什么类别,是否需要对其进行检测?
胶体金免疫层析试剂增加适用机型,需要提交哪些资料?
骨科植入器械力学性能研究应提供哪些资料?
定量检测体外诊断试剂产品说明书及技术要求中,对空白限、检出限及定量限有何要求?
体外诊断试剂临床试验中能否使用冻存样本?
在体外诊断试剂临床试验中,如采用核酸序列测定、GC-MS/MS 等实验室检测参考方法作为对比方法进行比较研究,是否可以委托测试?
注册申请人委托具备相应条件的企业生产医疗器械,委托方对受托方质量管理体系进行审核时应关注哪些内容?
新版《第一类医疗器械产品目录》实施后,在申报第一类医疗器械(非体外诊断试剂)产品备案时,哪些既往分类文件还可作为产品分类依据?
髋关节假体类产品通常在产品技术要求中规定哪些性能指标?