还是CNAS=GLP就可以吗？
　　A:FDA关于第三方检测实验室或机构的要求是：testing laboratory or certification body that was involved in determining the conformance of the device with the applicable consensus standard(s)that FDA has recognized or decided to recognize and reference any accreditations of those organizations.这里没有明确提出更为具体的检测机构的资质要求。
　　除了FDA 21CFR part 58里涵盖的试验，如生物学评价，需要满足GLP法规，FDA没有对三方实验室的资质要求。ASCA是美国FDA推出的一项自愿试点项目，并非强制要求。