Investigational Device Exemptions; Treatment Use

The Food and Drug Administration (FDA) is establishing procedures to allow for the treatment use of investigational devices. These procedures are intended to facilitate the availability of promising new therapeutic and diagnostic devices to desperately ill patients as early in the device development process as possible, i.e., before general marketing begins, and to obtain additional data on the device's safety and effectiveness. These procedures apply to patients with serious or immediately life-threatening diseases or conditions for which no comparable or satisfactory alternative device, drug, or other therapy exists.