An exemption from certain of the Federal Food, Drug, and Cosmetic Act's requirements for commercially available medical devices, an investigational device exemption (IDE) is required to conduct clinical trials of investigational devices.

The IDE allows manufacturers to ship investigational devices so that sponsors and investigators can conduct clinical studies that collect safety and effectiveness data. The studies typically support a premarket approval application, required to market certain devices commercially, but may sometimes be required for clinical studies that support certain premarket notification (510(k)) submissions.

A sponsor must submit an IDE application for Food and Drug Administration (FDA) approval for significant risk devices, which include devices that:

(21 C.F.R. § 812.3(m).)

Nonsignificant risk devices (as determined by the sponsor and institutional review board (IRB)) are deemed to have an approved IDE if the sponsor and investigator follow certain FDA regulations, including:

(21 C.F.R. § 812.2(b).)

An IDE application must provide the FDA with enough information to conclude that the proposed human trial is reasonably safe, including among other things:

(21 C.F.R. § 812.20.)