Scientific Advisory Panel on Software as a Medical Device (SAP-SaMD) Meeting Announcement
Announcement of meeting
Ottawa, Ontario
January 3, 2018
The purpose of this Notice is to announce an upcoming meeting of Health Canada’s Scientific Advisory Panel on Software as a Medical Device (SAP-SaMD).
This meeting will examine the regulatory oversight of the emerging field of software as a medical device.
Mandate of the SAP-SaMD
To provide timely scientific, technical, and medical advice on current and emerging issues related to software as a medical device.
The panel will focus on two main issues:
- The definition of SaMD and scope of what would be considered a medical device; and
- Provide feedback on a preliminary draft SaMD guidance document.
For more details, please refer to the Terms of Reference of the SAP-SaMD.
Meeting format
Health Canada will make a presentation to the panel summarizing background information, to provide context for the questions posed. This will be followed by presentations by the United States Food and Drug Administration and industry associations.
Upon completion of the presentations and associated discussion, the panel will deliberate in a closed meeting before providing their final advice to Health Canada.
Agenda
The detailed agenda for the meeting will be posted at a later date.