FDA CDRH issues 2016 regulatory science priorities

The FDA’s Center for Devices and Radiological Health this week released its regulatory science priorities for fiscal year 2016, picking out 10 areas of focus. The priorities will serve to improve safety, effectiveness, performance and quality of medical devices and radiation-emitting products, according to the agency, as well as facilitating the introduction of new devices into the marketplace. “We envision that our external stakeholders can use these priorities to better target their regulatory science resources as well complement these activities. In addition, we believe that collaboratively we can work to maximize the impact of regulatory science research investments,” the agency wrote in the report. Using “big data” to aid in regulatory decision making was 1st on the group’s list, followed by leveraging clinical experiential evidence and employing “evidence synthesis” across domains to aid in their regulatory decision making process. Big data has become a growing part of medical development, with data from implants and wearables changing how devices are created and designed. The federal watchdog said it set improving the reprocessing of reusable medical devices as a top priority. Infections and superbugs being spread by contaminated bronchoscopes and other scope imaging devices were major issues over the last year, and the FDA said it was “critical to develop a comprehensive approach to address the effectiveness of re...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news