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Compliance In Focus
Posted by John Lehmann on Mon, Dec 5, 2016

2017 CDRH Regulatory Science Priorities

The Center for Devices and Radiological Health (CDRH) recently issued its fiscal 2017 CDRH Regulatory Science Priorities.jpgregulatory science priorities. The list repeats some of the points highlighted in its 2016 list, while surfacing some new issues for consideration.

The CDRH started public disclosing it regulatory science priority list in FY 2015 and provides insight on how the agency will be directing its resources on regulatory science efforts.

Here is a listing of the CRRH’s regulatory science priorities in FY 2017. 
  1. Leverage “big data” for regulatory decision-making. 
  2. Modernize biocompatibility and biological risk evaluation of device materials. 
  3. Leverage real-world evidence and employ evidence synthesis across multiple domains in regulatory decision-making. 
  4. Advance tests and methods for predicting and monitoring medical device clinical performance. 
  5. Develop methods and tools to improve and streamline clinical trial design. 
  6. Develop computational modeling technologies to support regulatory decision-making. 
  7. Enhance the performance of digital health and strengthen medical device cybersecurity. 
  8. Reduce health-care-associated infections by better understanding the effectiveness of antimicrobials, sterilization and reprocessing of medical devices. 
  9. Collect and use patient input in regulatory decision-making. 
  10. Leverage precision medicine and biomarkers for predicting medical device performance, disease diagnosis and progression.

What is your reaction to the CDRH’s 2017 regulatory science priorities? Is this an improvement over the CDRH's 2016 regulatory science priorities? Share your thoughts below.

Data Safety Monitoring Boards and Clinical Events Committees


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Topics: CDRH, Regulatory Science Priorities, FY 2017


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