International Group Tackles ‘Software as a Medical Device’ Regulation
April 4, 2014 in News
On Wednesday, an international group of medical device regulators and stakeholders released a draft framework designed to harmonize regulation of software as a medical device, or SaMD, Health Data Management reports.
About the Group
The International Medical Device Regulators Forum’s SaMD Working Group was developed to create documents to detail different regulatory approaches to SaMD.
The group includes 10 countries:
- Sweden; and
- The U.S. (Slabodkin, Health Data Management, 4/3).
Details of Framework
The framework states that the “level of oversight should increase in line with the potential of a medical device to cause harm to a patient/consumer or user.”
Specifically, the framework outlines four levels of risk:
- Type 1, or very high impact, such as a device that can diagnose skin cancer;
- Type 2, or high impact, such as a device that examines physiological parameters to determine patient condition under intensive care;
- Type 3, or medium impact, such as a device that examines physiological parameters during routine checkups to determine long term progression of a condition; and
- Type 4, or low impact, such as a device that allows patients to track their daily health.
In addition, the framework identifies three recommended controls for SaMD:
- A quality management system;
- A system for post-market surveillance to determine the safety, effectiveness and reliability of the device; and
- Technical documentation to show how each SaMD was designed (IMDRF Framework, 3/26).