Welcome to the December 2025 issue of Regulatory Rapporteur  which focuses on North America.

We look at new FDA pilots and programmes launched amid a year of transformation in the US, and new substance notification processes and clinical data disclosure requirements in Canada. We also feature our six-monthly medical device standards update, further articles relating to MedTech innovation and the equity-centred regulation of digital mental health technologies, and a meeting report which summarises the presentations at the recent joint TOPRA/RAPS Regulatory Intelligence
Conference held in London.