FDA IDE：研究用器械豁免

When does a device study need an IDE? Under 21 CFR 812, an IDE lets an investigational device be shipped for a clinical study. Which approvals you need depends on risk. Start with the risk call. A significant risk device, which may include an implant or a device that supports life, needs FDA approval of the IDE as well as IRB approval, before any subject enrolls. IRB approval alone is not enough. There are three routes. Nonsignificant risk studies need only IRB approval, under abbreviated rules. Some studies, like a legally marketed device used as labeled, are exempt. And for an IDE, FDA has 30 days to object. And mind the words. FDA approves the investigation, not the device. While it is investigational, you may not promote it, test market it, or call it safe or effective for that use. Start with three things. One: make the risk call early, and ask FDA if unsure. Two: get IRB approval at every site. Three: label each unit as an investigational device. Settle the risk before enrolling. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.