Framework for the Clinical Evaluation of Devices for Male Circumcision

Framework for Clinical Evaluation of Devices for MC

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.

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Type: Document
Year of publication: 2012
Resource type: Policy or Guidance
Organization: WHO
Languages: English