The U.S. FDA’s agreement with industry for the fifth device user fee agreement (MDUFA V) included a pilot for the total product life cycle advisory program, or TAP, which is designed to ensure that potential device problems are addressed before production of the finished device design. However, the agency acknowledged that the TAP program will require significant numbers of new hires, which promises to be a significant hurdle given that the agency struggled to meet its hiring goals under the previous device user fee agreement.