Global group releases software as a medical device framework

Laura Pedulli | April 04, 2014 | Health Exec | Policy & Regulations

The International Medical Device Regulators Forum's Software as a Medical Device (SaMD) Working Group, which represents a voluntary group of regulators from 10 countries, has released a proposed framework to harmonize international medical device regulations as they relate to SaMD.

The 25-page report sets out to develop a common approach and understanding of SaMD risks and expected controls that promote safety and public health. This document provides an approach to:

Create a framework that categorizes types of SaMD based on their risk profiles.
Identify controls that assure safety and effectiveness required to address risks associated with different types of SaMD.
Identify essential information for describing the SaMD in terms of the medical purpose, context of use and core functionality
Characterize types of SaMDs, based on the essential information, similarity in risk profile and hazards associated with SaMD.
Identify measures considered appropriate for assuring reasonable safety and effectiveness.

Regulators can utilize this document as a reference when considering their regulatory requirements, according to the report.

Comments are invited on the framework by May 31. Read the report here.