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About Regulatory Science
Priorities For Assuring Safety, Effectiveness, Performance and
Quality of Medical Devices
FDA’s Center for Devices and
Radiological Health (CDRH) is responsible for assuring the safety,
effectiveness, performance and quality of medical devices and
radiation emitting products used to treat, prevent, and diagnose
disease throughout the product life cycle thereby reducing the
time to market, improving safety, and making the process
least burdensome.
CDRH has published FY 2017
regulatory science priorities to help focus the Center’s attention
on the most important regulatory science gaps or needs as under :
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Leverage “Big Data” for regulatory
decision-making
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Modernize biocompatibility and
biological risk evaluation of device materials
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Leverage real-world evidence and
employ evidence synthesis across multiple domains in regulatory
decision-making
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Advance tests and methods for
predicting and monitoring medical device clinical performance
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Develop methods and tools to improve
and streamline clinical trial design
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Develop computational modeling
technologies to support regulatory decision making
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Enhance the performance of Digital
Health and strengthen medical device cyber security
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Reduce healthcare associated
infections by better understanding the effectiveness of
antimicrobials, sterilization and reprocessing of medical devices
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Collect and use patient input in
regulatory decision-making
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Leverage precision medicine and
biomarkers for predicting medical device performance, disease
diagnosis and progression
Document providing an overview of
the process that CDRH used to generate these Priorities is
available at :
http://www.fda.gov/downloads/MedicalDevices/
ScienceandResearch/UCM521503.pdf
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