Federal Register Notice: FDA is making available a guidance for industry and FDA staff entitled Assayed and Unassayed Quality Control Material. The guidance details FDA's current practices on assayed and unassayed quality control material, including information to include in a 510(k) for assayed quality control material, and labeling recommendations. These materials are intended to monitor reliability of a test system and help minimize reporting of incorrect test results. They are often the best source of ongoing feedback that a laboratory has to monitor whether results reported to physicians are sufficiently reliable. To download this guidance, click here. To view this notice, click here.