The Prescription Drug User Amendments (PDUFA), Medical Device User Amendments (MDUFA), and other important pieces of FDA legislation such as the 21st Century Cures Act, provide FDA with vital resources and policy advancements to carry out its public health mission and ensure that patients have timely and continued access to safe, effective, and high-quality medical products. Since FDA’s Office of Combination Products was first established through the Medical Device User Fee and Modernization Act of 2002, critical pieces of legislation have helped streamline combination product development through capacity building, guidance development, and process improvements. This session will highlight these advancements in combination product policies and the continued collaborative efforts across FDA’s product centers and stakeholder communities.