Investigational Device Exemption (IDE)
An investigational device exemption (IDE) allows an unapproved medical device to be shipped and used in a U.S. clinical investigation — with FDA approval required before significant-risk studies may begin.
Video guide
FDA IDE: Investigational Device Exemptions
Learn how investigational device exemptions apply to device studies, risk determinations and FDA approval.
Open video pageTranscript (English)
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.
What is an investigational device exemption?
Devices normally may not enter U.S. commerce without authorization; an IDE exempts a device from that rule so it can be studied clinically. For a significant-risk device, the sponsor must obtain FDA approval of the IDE application and institutional review board (IRB) approval before enrolling subjects; informed consent, monitoring, labeling ("CAUTION — Investigational device") and records requirements apply throughout.
What is the difference between significant-risk and nonsignificant-risk studies?
A significant-risk device presents potential for serious risk to subjects — implants, life-supporting devices, and devices of substantial importance in diagnosing or treating disease. Nonsignificant-risk studies do not require an FDA submission; IRB approval and abbreviated IDE requirements suffice. The risk determination is made per study, initially by the sponsor and IRB, and the FDA can be asked to decide — getting it right early prevents an enrollment stoppage later.
When does a device program need an IDE at all?
When U.S. clinical data is needed — most commonly to support a PMA, sometimes a De Novo or a clinically driven 510(k). Studies of legally marketed devices used within their cleared or approved intended use generally do not require an IDE. Foreign clinical data can support U.S. submissions when it meets FDA's acceptance criteria, so an IDE is not automatically part of every Class III program.
How does an IDE study connect to design controls?
An investigational device must still be developed under design controls, and the investigation itself generates the design validation evidence a submission will later present. Good clinical practice for device studies is addressed internationally by ISO 14155, which the FDA recognizes — relevant for manufacturers running multi-country programs alongside a United States study.
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