To support rapid scale-up of medical male circumcision (MMC) for HIV prevention in settings with high HIV incidence and low prevalence, WHO and other health agencies sought to identify technologies to make MMC more cost-effective, safer, easier to implement than surgical methods, and with a shorter recovery time. Regulations on approval of such medical devices for use outside the body may only call for limited clinical trials. However, since MMC is a public intervention to be used on a large number of men, circumcision technology should receive rigorous review. This framework outlines a progressive series of clinical studies to establish the safety, efficacy, acceptability, and clinical function of devices for medical male circumcision when used by trained, mid-level health care providers in public health programs in resource-limited settings. It is intended for use by product developers, clinicians involved in testing devices, regulators, program managers, and donors. The document also notes some regulatory and manufacturing considerations, bridging studies, and implementation studies' and provides information on monitoring programs.