Developed by WHO through its Technical Advisory Group on Innovations in Male Circumcision, this document focuses mainly on clinical requirements for assessing the suitability of a device for male circumcision for use in public health HIV prevention programmes in resource-limited settings and, secondarily, on regulatory and manufacturing considerations. It describes a series of steps and clinical studies to evaluate the clinical performance, safety, and acceptability of a new male circumcision device. The framework also provides suggestions for a phased introduction of male circumcision devices within national programmes.