Integrating patient registries and innovative tools for enhanced medical device evaluation and tracking

Registries of patients undergoing medical device procedures represent a growing potential electronic resource for local and global medical device evaluation and tracking. To integrate such established data resources with new tools (such as UDIs) and optimize their regulatory applications, shared essential principles of informatics infrastructure and best epidemiologic and statistical analytic methodologies could enhance the quality, speed and cost-efficiencies of regulatory science for medical devices. Therefore, the purpose of this Work Item is to collaboratively develop a shared set of those essential principles. 'Essential principles' in the scope of this work are intended to encourage consistency and transparency across global efforts without prescribing them as 'required' in any way.