The influence on Medical Device’s Regulatory Decision Making

Centre for Devices and Radiological Health (CDRH), a division of US Food and Drug Administration (FDA) seems to be all set to enhance the quality of Medical Devices and Radiation-emitting products in order to ensure the patient safety. Emphasizing the same, Regulatory science at CDRH has released a set of priorities for FY 2017 stressing more on modernization availing Big Data and real-world evidence.

What is Regulatory Science?

As defined by CDRH, regulatory science is a science in the service of regulation. It develops and applies standardized tools and methodologies to study safety and effectiveness of medical devices and radiation-emitting products and helps in ensuring the regulatory decisions are well-founded and targeted at achieving the desired impact on public health.

In 2015, the center has published its first set of priorities for 2016. Increasing its outreach for FY 2017, it has been learned that the center was able to identify new topic areas sourced through more needs submissions from internal staff.  In the new priority list, the center has discussed the new topic areas (clinical trial design, and precision medicine) as well as described existing topic areas in a detailed fashion. Majorly focused on influencing the Regulatory decision making for medical devices and radiation-emitting products, the CDRH’s comprehensive list of top 10 priorities for FY 2017 includes:

  • Leveraging “Big Data” for Regulatory decision-making
  • Modernization of biocompatibility and biological risk evaluation of device materials
  • Leveraging real-world evidence and employing evidence synthesis across multiple domains in regulatory decision-making
  • Enabling advanced tests and methodologies for medical device clinical performance prediction and monitoring
  • Developing methods and tools for improving and streamlining clinical trial design
  • Developing computational modeling technologies for supporting regulatory decision making
  • Enhancing digital health performance and strengthening medical device cybersecurity
  • Reducing healthcare-associated infections with better understanding on the effectiveness of antimicrobials, sterilization and reprocessing of medical devices
  • Collecting and using patient input in regulatory decision-making
  • Leveraging precision medicine and biomarkers for prediction of medical device performance, disease diagnosis and progression

As a heads up, the CDRH priority list set for FY 2017 stands an advanced indication for medical devices and radiation-emitting products’ manufacturers to be aligned with compliance requirements. Take an insightful and informed decision by consulting a global Regulatory partner.


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