Software as Medical Devices (SaMD) – Where to go from here?

Author: Karen Zhou

In an era of mobile apps on smartphones and tablets, Canada’s current software regulatory framework is long overdue for revision. Because the healthcare industry has become more reliant on software, Health Canada has recognized the need to revisit the current medical device regulatory framework as it applies to software as medical devices. This is to ensure the regulatory requirements remain flexible enough to account for the rapid pace of technology, and also to ensure that safe and effective products can be brought to market in a timely manner.

A scientific advisory panel consisting of regulators (Health Canada and FDA) and industry representatives (MEDEC and Council of Canadian Innovators (CCI)) convened this past January to discuss current and emerging issues related to software as medical devices. 

Health Canada acknowledged that current classification rules were defined 20 years ago and do not reflect current technology.  Canada is due for a guidance document addressing how to classify this technology.  In response to the issue of classification, Bakul Patel, on behalf of the FDA, explained the approach taken by both the US agency and the IMDRF (International Medical Device Regulatory Forum).  The FDA described three types of medical device software: software in a device; software as a device; and software used in the manufacturing process of a device. Additionally, the FDA also has a Pre-Certification program as a regulatory approach for SaMD that relies on a company’s demonstrated culture of quality.  From the FDA’s perspective, it is important to look at how quickly the products change and evolve in order to develop a regulatory process that will not impede progress but at the same time ensuring the makers are reliable.

Both MEDEC and CCI raised industry concerns. CCI talked about the market challenges and the issues missed by the IMDRF, which include software change management, data ownership, agile development, and machine learning. MEDEC pointed out that SaMD is a special medical device. For example, the software cannot act on its own and needs an interface.  Also, frequent changes within SaMDs require regulations to clarify when a change requires premarket approvals or postmarket notifications.  A risk-based regulatory framework as applicable to SaMD should provide guidance to appropriate activities for design and manufacture.

Health Canada also reviewed the draft SaMD guidance (unpublished) intended to clarify what SaMD is and to provide guidance on how SaMD may be classified.  Some issues raised by the panel include whether manufacturers can follow guidelines, which serve to clarify regulations but do not address the design and development aspects of a product; and how Health Canada can borrow from existing frameworks to devise different requirement for these products.  It is expected that the comments and advice from the meeting will be analyzed for revising the draft guidance document. It is Health Canada’s intention to release the finalized document in 2018.

Reference

Scientific Advisory Panel on Software as a Medical Device (SAP-SaMD) - Record of Proceedings – January 26, 2018

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/scientific-expert-advisory-panels/software-medical-device/record-proceedings-2018-01-26.html