CDRH Releases FY 2017 Regulatory Priorities

By MedTech Intelligence Staff

Highlights include leveraging big data, streamlining clinical trial design, reducing healthcare-associated infections and toughening up on cybersecurity.

Today CDRH issued its regulatory science priorities for FY 2017. The goal is to boost device safety and effectiveness, performance and quality. The priorities are:

  • Use big data for regulatory decision-making
  • Modernize biocompatibility and biological risk evaluation of device materials\
  • Leverage real-world evidence and use evidence synthesis across multiple domains in regulatory decision-making
  • Advance tests and methods for predicting and monitoring clinical performance of medical devices
  • Develop methods and tools to improve and streamline clinical trial design
  • Develop computational modeling technologies to support regulatory decision-making
  • Enhance the performance of digital health
  • Strengthen medical device cybersecurity
  • Reduce healthcare-associated infections by better understanding the effectiveness of antimicrobials, sterilization and reprocessing of medical devices
  • Collect patient input for regulatory decision-making
  • Leverage precision medicine and biomarkers for predicting device performance, disease diagnosis and progression

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