According to a recent Government Accountability Office (GAO) report, the FDA faces challenges fulfilling its growing medical product oversight responsibilities, particularly those not funded by industry user fees. While FDA reports that funding levels allow it to address the most urgent needs and priorities, the agency did not receive enough resources to meet some statutory requirements, such as biennially inspecting certain manufacturing establishments. The GAO recommends that the FDA establish a comprehensive and reliable basis for substantiating the agency’s resource needs; the FDA concurred.