WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices 7.3-EUA: Applicants for emergency use authorization submit the evidence available, keep seeking and submitting new evidence, monitor post-market safety and performance, and move to full assessment within the limited validity period

What does 7.3-EUA require?

In a public health emergency the NRA may authorize previously unmarketed devices needed to diagnose, treat or prevent the emergency condition where no safe and effective alternative is available and preliminary evidence suggests benefits outweigh known risks. The applicant must actively look for and submit further evidence as it emerges, the manufacturer should continuously monitor post-market safety and performance data, and once enough data exist a full routine assessment follows; emergency authorizations have a limited, published validity so that expired products are not bought or used.