Global Medical Device Clinical Trials Involving Both the United States and Japan: Key Considerations for Development, Regulatory Approval, and Conduct
Device Approval
New Humanitarian Device Approval
Faster approval for breakthrough devices
Contraceptive device not likely to win US approval
New Lancing Device Approved
The Device Approval Process
Spinal devices in the United States—investigational device exemption trials and premarket approval of class III devices
Post-approval study of a highly pulsed, low-shear-rate, continuous-flow, left ventricular assist device, EVAHEART: A Japanese multicenter study using J-MACS
Radiological Medical Device Innovation: Approvals via the Premarket Approval Pathway From 2000 to 2015
