Medical Devices

Mission, Objectives, and Strategy

Mission:

To bridge evidentiary gaps, to develop datasets and innovative methodological approaches for conducting robust analytic studies to improve medical device safety and effectiveness understanding throughout the device life cycle.

Objectives:

  • Improve how medical device information is utilized throughout the life cycle of a device.
  • Synthesize evidence from pre-market clinical trials, post-approval observational studies, domestic and international registries, medical claims data, and published literature on how medical devices are used throughout their life cycle.
  • Develop a conceptual framework for comparative effectiveness that examines relationships between and among medical treatments, patient outcomes, medical devices, resulting in development of novel study designs and analytical strategies, and application of these scientific advancements to CDRH regulatory decision making.
  • Advance the development and testing of new approaches to medical device studies that address the device’s life cycle.
  • Collaborate as co-authors/peer reviewers to communicate MDEpiNet work results.

Strategy:

  • Systematically evaluate and integrate evidence of risks and benefits associated with medical devices into regulatory science.
  • Collaborate with external parties with relevant expertise to determine evidence gaps, study questions, datasets and best practices.
  • Incorporate appropriate study designs, analytical strategies, and regulatory decision making to develop a framework for patient-centered outcomes in medical device study and regulation.
  • Develop, test and disseminate innovative methodological approaches and study results in medical device research.
  • Leverage partner resources and expertise to create a sustainable infrastructure that stakeholders can use to obtain knowledge about medical devices.
  • Fully integrate the MDEpiNet infrastructure into CDRH decision making and the systematic evaluation of medical devices.

 

Page Last Updated: 11/04/2014
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