Revised IDE guidance articulates investigational device "compassionate use" policy.
This article was originally published in The Gray Sheet
Executive Summary
REVISED IDE GUIDANCE ARTICULATES "COMPASSIONATE USE" POLICY, allowing for use of investigational or unapproved devices outside of an investigational device exemption for patients with serious conditions. The final guidance, dated Jan. 20, sets in writing FDA's informal policy of approving IDE supplements for "compassionate use" of a device on an individual or small group of patients with a serious, but not life-threatening, condition. FDA handles a few requests each year for compassionate use approval.