Last month the FDA’s Center for Devices and Radiological Health (CDRH) released their Top 10 Regulatory Science Priorities for 2016. As noted in their report:
“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. It helps 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.” (p. 5)
The list includes:
- 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
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