The World Health Organization, supported by global partners, defined a pathway for the evaluation of the safety and efficacy of male circumcision devices, set priority criteria, and established a process to guide the use of such devices in publicly funded voluntary medical male circumcision (VMMC) programmes for HIV prevention. This article describes the development of the pathway, criteria, and process and how they were used to evaluate and ultimately prequalify the PrePex and ShangRing devices. The article is part of a special supplement of the Journal of Acquired Immune Deficiency Syndromes about studies on the introduction of the two devices.