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).
|"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|