Request for Information (RFI): MDEpiNET PPP

FDA is interested in obtaining multi stakeholder input related to the operations of the MDEpiNet PPP, to ensure that it is developed in a way that supports not only FDA, but the missions of other participating partners, thus providing the maximum impact on public health. This RFI is focused on better understanding of capabilities and approaches for the management of the MDEpiNet PPP to support the national postmarket surveillance plan. Specifically, FDA requires input related to the following questions: What role is envisioned for partners representing the patient, government, medical device industry, academia, health care providers, professional organizations, health care payer, and other sectors, and what are the parameters for their membership in the MDEpiNet PPP? Which additional partnership sectors should be represented, if any, and are there specific groups without whom the MDEpiNet PPP would not meet its mission? How would governance balance the desire for a comprehensive representative body against the need for nimble operations, usually accomplished through a small empowered team? What financial model(s) would best support the startup and sustained management of the PPP through the partnership management center? What are the ideal project proposal, selection, funding, and management models that would allow for appropriate buy-in and coordination, while allowing for scientific independence of investigators? What is the projected annual cost of operations, and what would be the ideal breakdown of federal and private funding to meet those needs?