IMDRF: Regulators offer updates on new working group documents

Editor's note: A previous version of this article contained a misspelling of one of the speaker's names. Regulatory Focus regrets the error.

WASHINGTON – Panelists at the 25^th session of the International Medical Device Regulators Forum (IMDRF) updated attendees on the work of the organization’s working groups. They noted that stakeholders may expect guidance documents harmonizing global marketing review requirements and considerations for device and risk characterization later this year.
 
On 12 March, Stephanie Shedd, an international policy analyst at the US Food and Drug Administration (FDA), updated attendees on the progress various IMDRF working groups have made and what stakeholders can expect from them in the coming year.  She noted the work of the Adverse Events Terminology Working Group, which aims to improve, harmonize, and expand terminology used to code information related to adverse events.
 
Shedd added that the group is continuing to work on developing common data set for adverse events reporting and ensuring such data can be exchanged between regulators. She also noted the group is conducting a third pilot project to share large data sets and developing a new document outlining what regulators should consider when determining code selection.
 
“The document will provide additional guidance on how to use the coding sets in conjunction with maybe another coding system to fully capture the adverse event,” said Shedd.
 
Shedd talked about the Good Regulatory Review Practices Working Group, which is working to develop documents that harmonize global marketing review requirements. She noted that Health Canada is already piloting the eSTAR project to that end, and the working group has been making minor revisions to improve clarity and consistency and clarify the scope and interrelationships between the documents they are responsible for, which they plan on proposing later this year.
 
Shedd discussed the progress of the Artificial Intelligence/ Machine Learning Working Group, which provides fundamental principles and promotes the development of AI/ML-enabled medical devices. She said the group is currently drafting a document on guiding principles for good machine learning practices (GMLP) based on early trilateral documents developed by regulators in the UK, Canada, and US which reflect recent advances in AI/ML technology.
 
Shedd also noted two working group subgroups are addressing the needs of generative AI and large language models and ensuring alignment with other IMDRF documents. She said stakeholders can expect to see the documents out for public consultation this summer or fall. She also noted that the working group wants to address GMLP predetermined change control plans and possibly AI life cycle management issues.
 
Shedd discussed the progress made by the Personalized Medical Devices Working Group, which is tasked with developing technical guidance and harmonized recommendations for regulating personalized medical devices. She said the group proposed a plan to develop training materials for personalized medical device stakeholders that will be discussed later in the week and would include new definitions and concepts for regulating personal medical devices, point of care, and manufacturing for such devices.
 
Finally, Shedd updated attendees on the work of the Quality Management System Working Group, which is continuing to work on updating the Global Harmonization Task Force (GHTF) supplier controls document. She said the group plans to submit its proposed updated document to the IMDRF management committee sometime this year.
 
MiRa Jacobs, acting assistant director for Digital Health Policy at the Digital Health Center of Excellence at FDA, updated attendees on the Software as a Medical Device (SaMD) Working Group, which aims to promote greater global convergence of pre- and post-market regulatory review. She noted that over the past decade, the group has published several documents that likely need to be updated.
 
“The space has continued to advance very rapidly, and it's probably also fair to say that the last 10 years have probably really tested these documents,” said Jacobs. “The working group feels that, of course refinements are still needed to continue to improve convergence and consistency in this area and that has sort of led us to our most recent document.”
 
She noted that the working group has published a document on considerations for device and risk characterization, which adds to previous documents on providing a clear and accurate characterization of medical device software. The document highlights topics such as the importance of having comprehensive characterization for medical device software, establishing key features and common vocabulary, identifying fundamental elements of the intended use and purpose, and establishing links between characterization features and risks.
 
“The document that we've put out for comment now is sort of talking about a bridge towards continuing to refine a harmonized risk categorization framework,” said Jacobs. “I'll say this a bunch, but please do take a read of that document and provide your comments.”
 
She said the IMDRF Management Committee approved the document in January and is open for public comment until May, and the final draft is expected to be published later this year.
 
Daniel Yoon, a regulatory advisor at Health Canada and co-chair of the Regulatory Product Submission Working Group, said his group has developed a table of contents to provide a harmonized format for regulatory submissions, but after creating it, they realized it had technical limitations that prevented it from being adopted broadly. As a result, he noted the IMDRF Management Committee approved an extension in 2021 so the group could explore a new dynamic submission template, which has led to significant updates.
 
In January 2023, the IMDRF Management Committee approved opening public consultation to update a couple of documents on regulatory product submissions and Yoon said his working group has accepted about 60% of the changes proposed by stakeholders. If the IMDRF Management Committee also approves the changes, he said the working group will focus on developing the dynamic submission template.
 
"This will include leveraging the updated [table of contents (TOC)] requirements, determining a governance structure, and developing the mechanism for keeping requirements current," said Yoon "Aside from containing the TOC requirements, a dynamic template can help applicants verify that the necessary information is provided in a standardized, accessible format and ultimately help enable regional participants to quickly process submissions."
 
Yoon added FDA’s eSTAR dynamic template is an example of a template that could be used to guide applicants through their regulatory submission, and noted Health Canada is currently testing it in a pilot project.