This document is the fourth issued by the International Medical Device Regulatory Forum (IMDRF) that provides a path for global regulators to converge on terminology, a risk-based framework, an understanding of quality management system principles, and in this document, an approach to making Software as a Medical Device (SaMD) clinically meaningful to users. This document focuses on the activities needed to clinically evaluate SaMD — and relies on the reader to gain knowledge from the previous documents as a pre-requisite to this document.

This document, and previous documents, provides harmonized principles for individual jurisdictions to adopt based on their own regulatory framework. They are not regulations.

This document describes a converged approach for planning the process for clinical evaluation of a SaMD (software with a medical purpose as defined in SaMD N10) to establish that:

  • There is a valid clinical association between the output of a SaMD and the targeted clinical condition (to include pathological process or state); and
  • That the SaMD provides the expected technical and clinical data.

The knowledge gained from previous documents is critical to the understanding of information in this document. This document builds on previously introduced vocabulary, risk-based considerations, and SaMD lifecycle processes and activities to help emphasize the clinical considerations essential to the success and adoption of SaMD.

Posted on the FDA website on 8 December 2017