Satisfying the Requirements of the Food and Drug Administration and Centers for Medicare and Medicare Services

Clinical studies of new imaging technologies conducted for regulatory purposes have traditionally focused on satisfying the standards of the US Food and Drug Administration (FDA) for marketing clearance or approval of a new product. However, given the increased scrutiny that is being directed at diagnostic imaging by third-party payers, obtaining clinical data that can support Medicare coverage of a new imaging technology is increasingly important to ensure the maximum diffusion of that technology. This article describes the regulatory requirements of both the FDA and Centers for Medicare and Medicare Services and explains how sponsors may approach clinical studies to secure both FDA clearance or approval and Centers for Medicare and Medicare Services coverage and payment.