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Health Canada Puts Brakes on SaMD Draft Guidance

Posted 19 October 2018 | By Ana Mulero 

Health Canada Puts Brakes on SaMD Draft Guidance

A scientific advisory panel on software as a medical device (SaMD) convened in January by Health Canada caused the agency to hit the brakes on a draft guidance document.

The advisory panel, which included the US Food and Drug Administration (FDA), Canada’s medical technology companies (MEDEC), the Council of Canadian Innovators (CCI) and the National Research Council, among others, deliberated on questions Health Canada provided regarding its draft guidance on SaMD classification ahead of the January meeting.

Health Canada, at the time, intended to release its drafted policies over the summer. But the record of proceedings posted Wednesday suggests that the advisory panel’s recommendations deterred these plans as they were not carried out by the agency within the specified timeframe.

The presentations during the advisory panel’s meeting discussed a range of issues related to the regulation of digital health technologies based on the risk-based SaMD definition developed via the International Medical Device Regulators Forum (IMDRF) a few years ago. Bakul Patel, associate director for digital health at FDA’s Center for Devices and Radiological Health (CDRH), kicked off the presentations by describing how CDRH is working with IMDRF to tackle the issue facing many other regulatory agencies.

The issue relates to the lack of a regulatory approach tailored to the iterative nature of digital health solutions. It has been exacerbated in recent years as the global digital health market continues to grow at an unprecedented rate, partly fueled by demand, leaving regulators in the challenging position of attempting to catch up and keep pace by re-evaluating existing policies.

Draft guidance?

Patel, who also serves as lead of the IMDRF SaMD working group, reportedly urged Health Canada to look at the fast-paced cycle for products in this space to evolve. He noted this assessment will help to “develop a regulatory process that is not stopping this progress” and to “make sure that makers of these products are reliable,” according to the record of proceedings.

Health Canada was convinced, concluding and reiterating that “there is a real paradigm shift here. Maybe we need to step back and look at it [the draft guidance] again.” The questions for the advisory panel were separated into two parts to direct the focus on the draft guidance first.

A new stance was detailed after the meeting. In an April notice, Health Canada announced its decision to expand on an existing initiative to improve the overall regulatory system and establish a new Digital Health Review Division “to allow for a more targeted premarket review of digital health technologies.” The division is charged with six focus areas in addition to SaMD.

It “brings increased expert review capacity for medical devices integrating digital health technologies and will also develop a targeted review process and work towards better alignment with other regulatory agencies and stakeholders,” Health Canada said, adding that establishing the division “is a first step towards a regulatory approach adapted to keep pace with innovation.”

The notice provided few details, though plans under the larger initiative included exploring ways to expedite premarket applications for new digital health technologies. Specific tasks set on the initiative’s project for greater access to digital health included establishing the division and a new scientific advisory committee and an “ongoing re-evaluation of business processes” from March 2018 to March 2020, with the expectation to have all parts “fully in place by fall 2020.”

Second round of questions

The second portion of questions was specifically intended to gain insights from the panel members on whether Health Canada should seek to regulate SaMD within its current regulatory framework, modify this framework or create a new one for a more modern approach to SaMD.

Following Patel’s presentation, the panel deliberated around whether Health Canada should consider a paradigm shift similar to the one currently being developed in the US through CDRH’s Pre-Certification (Pre-Cert) pilot program. Similarly, CCI members encouraged Health Canada to “gain some experience on how software is developed” by visiting firms in-person.

A concern raised in the meeting relates to whether it would be a “better fit” to incorporate the Pre-Cert model into an organization such as the International Organization for Standardization (ISO) “so that all companies can apply it and it would be recognized by everyone.” This was echoed by CCI, stating that “Canada has a much smaller market and should work to harmonize US FDA and Canadian regulations for improved patient access and better market access.”

The concept around evaluating SaMD based on a demonstrated history of organizational excellence was also previously developed via an IMDRF document on the principles for establishing a harmonized approach to the application of quality management systems for SaMD developers based on existing requirements in member countries and ISO 13485.

“These principles are the foundation for good practices to maintain and control the quality of products in organizations of any size, ranging from a one-person enterprise to a multi-national corporation,” the 2015 IMDRF final document states. CDRH’s Pre-Cert framework, which is still a work in progress, also used these SaMD quality management principles as its foundation.


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