Federal Register Notice: FDA is making available a guidance entitled Custom Device Exemption. The agency defines terms used in the custom device exemption, explains how to interpret the “five units per year of a particular device type” language contained in the FD&C Act, describes information that it proposes manufacturers should submit in the custom device annual report, and provides recommendations on how to submit an annual report for devices distributed under the custom device exemption. To download this guidance, click here. To view this notice, click here.