CDRH Regulatory Science Priorities

CDRH's regulatory science priorities serve as a catalyst to improve the safety, effectiveness, performance, and quality of medical devices and radiation-emitting products, and to facilitate introducing innovative medical devices into the marketplace.

These regulatory science priorities help focus the Center's attention on the most important regulatory science gaps or needs. The priorities will be reassessed and updated periodically to reflect current regulatory science needs.

Overview of Priority Areas

The following table provides an overview of the current regulatory science priority areas. For details on each of the areas, see the CDRH Regulatory Science report (PDF).

	Area	Priority
	"Big Data"	Leverage "Big Data" for regulatory decision-making
	Biocompatibility	Modernize biocompatibility and biological risk evaluation of device materials
	Real-world evidence	Leverage real-world evidence and employ evidence synthesis across multiple domains in regulatory decision-making
	Clinical performance	Advance tests and methods for predicting and monitoring medical device clinical performance
	Clinical trial design	Develop methods and tools to improve and streamline clinical trial design
	Computational modeling	Develop computational modeling technologies to support regulatory decision-making
	Digital Health and cybersecurity	Enhance the performance of Digital Health and medical device cybersecurity
	Healthcare-associated infections	Reduce healthcare associated infections by better understanding the effectiveness of antimicrobials, sterilization and reprocessing of medical devices
	Patient input	Collect and use patient input in regulatory decision-making
	Precision medicine and biomarkers	Leverage precision medicine and biomarkers for predicting medical device performance, disease diagnosis, and progression