Investigational Device Exemption (IDE)

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.