Devices

CDRH Regulatory Science Priorities

CDRH is listing its 10 current regulatory science priorities that “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.” An online list gives the 10 as:

leverage “Big Data” for regulatory decision-making;
modernize biocompatibility and biological risk evaluation of device materials;
leverage real-world evidence and employ evidence synthesis across multiple domains in regulatory decision-making;
advance tests and methods for predicting and monitoring medical device clinical performance;
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 medical device cybersecurity;
reduce healthcare-associated infections by better understanding the effectiveness of antimicrobials, sterilization, and reprocessing of medical devices;
collect and use patient input in regulatory decision-making; and
leverage precision medicine and biomarkers for predicting medical device performance, disease diagnosis, and progression.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome