Focusing on using big data and analytics to make regulatory and clinical decisions, CDRH has released its top priorities for next year. Released yesterday, “Regulatory Science Priorities (FY2016)”, was compiled by the CDRH Center Science Council’s Regulatory Science Subcommittee (RSS).
The center defines regulatory science as “science in the service of regulation”. CDRH’s goal within this area is to improve the assessment of device safety, effectiveness, quality and performance. Its priorities for fiscal year 2016 as outlined in the agency document are as follows:
- 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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