Medical Devices

Regulatory Science Priorities


FY2016 Regulatory Science Priorities

The CDRH regulatory science priorities serve to accelerate improving the safety, effectiveness, performance and quality of medical devices and radiation-emitting products, and to facilitate introducing innovative medical devices into the marketplace. The priorities help the Center address the most important regulatory science gaps or needs. These priorities will be reassessed and updated periodically to reflect current regulatory science needs.

We envision that our external stakeholders can use these priorities to better target their regulatory science resources as well complement these activities. In addition, we believe that collaboratively we can work to maximize the impact of regulatory science research investments.
  • Leverage “big data” for regulatory decision making
  • Leverage evidence from clinical experience and employ evidence synthesis across multiple domains in regulatory decision making
  • Improve the quality and effectiveness of reprocessing reusable medical devices
  • Develop computational modeling technologies to support regulatory decision making
  • Enhance performance of Digital Health and medical device cybersecurity
  • Incorporate human factors engineering principles into device design
  • Modernize biocompatibility / biological risk evaluation of device materials
  • Advance methods to predict clinical performance of medical devices and their materials
  • Advance the use of patient reported outcome measures (PROMS) in regulatory decision making
  • Collect and use patient experience/preference in regulatory decision making

Page Last Updated: 10/20/2015
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