Framework for clinical evaluation of devices for adult male circumcision
The purpose of this document is to provide a framework for the clinical assessment of male circumcision devices for adult male circumcision in programs to expand male circumcision for HIV prevention. The document gives background on male circumcision and why it is recommended for HIV prevention. Next, it presents a review of the potential for male circumcision devices (once shown to be acceptable, safe and effective in the target population) to facilitate rapid expansion of adult male circumcision services in resourcelimited settings. This is followed by a summary of different medical device regulatory systems with special reference to male circumcision devices in the country of origin, the country of use of the device, as well as considerations for sponsors of research and/or programmes.