Forty-five guidance documents on medical devices and diagnostics issued by regulatory authorities from around the world were added to Medtech Insight’sGuidance Tracker in the past month.
The updated tracker includes guiding principles jointly developed by regulators in the US, Canada and the UK regulators on predetermined change control plans (PCCP) for machine learning-enabled medical devices. They aim to support sponsors by reducing the regulatory burden of reassessment following certain changes and updates to their devices
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