Humanitarians, compassion, and the food and drug administration: Guidance for the practitioner

Abstract

Once an HUD finds its way to the shelves in a hospital's procedure room, there is a possibility that the practitioner will find applications for the device beyond its intended use. In many or most of these cases, the patient would probably benefit from its use, but the practitioner should be cognizant of FDA recommendations and requirements surrounding such off-label applications. It is strongly recommended that practitioners work closely with their local IRBs for any intended off-label use. It is hoped that this brief review not only will focus proper attention on these federal recommendations but also will bring to light ongoing shortcomings in accumulation of published data on these HUDs.