Health Canada is seeking comments from stakeholders on its plan to “pause the clock” during reviews of medical devices under specific circumstances.
The mechanism would help sponsors meet review deadlines and help resolve any issues that arise without incurring penalties.
The mechanism would be implemented only for specific circumstances that would not normally arise under the review process. For example, Health Canada would be able to pause the clock for medical device applications linked together that have different review times, or for a sponsor’s extension request. The department would also be able to pause the clock when it seeks advice from expert panels during reviews.