The Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) published its regulatory science agenda for fiscal year (FY) 2017. The regulatory science priorities serve as a guide for making strategic intramural research funding decisions to ensure that CDRH research is focused on needs that are relevant and critical to medical devices and radiation-emitting products.
Several of CDRH’s priorities are health IT-related or utilize technology, including: leverage “Big Data” for regulatory decision-making; develop methods and tools to improve and streamline clinical trial design; develop computational modeling technologies to support regulatory decision-making; enhance the performance of Digital Health and strengthen medical device cybersecurity; collect and use patient input in regulatory decision-making; and, leverage precision medicine and biomarkers for predicting medical device performance.
For leveraging big data, CDRH is interested in harvesting, validating organizing and disseminating information in data warehouses to streamline regulatory decision-making throughout the medical device total product lifecycle. According to CDRH, it is fundamental to develop the necessary infrastructure, statistical or analytical tools and models, information retrieval and processing for big data, relevant to enhancing safety, performance and quality of medical devices.
Moreover, the idea of leveraging precision medicine to help predict medical device performance, CDRH is emphasizing precision medicine during the device lifecycle as a means to obtain better focused indications and clinical studies as well as device optimization. Regulatory science for precision medicine includes research efforts such as developing patient-specific cell models to test medical devices.
CDRH is responsible for assuring the safety, effectiveness, performance and quality of medical devices and radiation-emitting products used to treat, prevent, and diagnose disease. The mission of CDRH is to protect and promote public health. CDRH facilitates medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.