The FDA has released the Chemicals List for Analytical Performance, a chemical dataset that is intended to aid medical device sponsors in the biocompatibility testing and review processes. "A central tenet of the [Center for Devices and Radiological Health] biocompatibility evaluation is for sponsors to have the option, for some biocompatibility endpoints, to undertake extraction studies to identify and quantify chemicals released from a device and then to perform a toxicological risk assessment (TRA) to determine if the chemicals pose safety issues in the use of the device," said CDRH Director Jeff Shuren.