FDA CDRH Regulatory Science Priorities

The U.S. Food and Drug Administration Center for Devices and Radiological Health (CDRH) recently released its Regulatory Science Priorities (FY 2016), which will “serve to accelerate improving the safety, effectiveness, performance and quality of medical devices and radiation-emitting products, and to facilitate introducing innovative medical devices into the marketplace.”  This CDRH report will guide intramural research funding decisions, and serve as an aide for external stakeholders to target their resources to complement CDRH research activities.  Two of the top ten Regulatory Science Priorities are:  Leverage “Big Data” for regulatory decision making; and Leverage evidence from clinical experience and employ evidence synthesis across multiple domains in regulatory decision making.  “Big Data warehouses such as the human genome sequence database contain a wealth of scientific and clinical information relevant to the safety, performance and/or quality of medical devices.”  Such information “can potentially enhance the quality and effectiveness of regulatory decision making” as well as “aid the regulatory process by streamlining scientific review and identifying potential emerging post-market issues earlier in the process.”  For additional information, connect to the FDA – Medical Devices – Science & Research (Medical Devices) – Regulatory Science Priorities page.