FDA proposes changes to postmarket surveillance system for medical devices


Intravenous news: Infection Control Today report “The Association for the Advancement of Medical Instrumentation (AAMI) is reporting on the Food and Drug Administration (FDA)’s proposed series of steps to strengthen and modernize its postmarket surveillance of medical devices. The “smart, tailored modifications” will, according to the agency, both bolster patient safety and help to expedite clearance of new devices or new uses for existing devices through the faster generation of more comprehensive data.

The proposed changes are outlined in a 25-page report released by the FDA, “Strengthening Our National System for Medical Device Postmarket Surveillance.” Several aspects of the report have already been made public by the agency, such as the proposed use of unique device identifiers (UDI). But the report provides the agency’s most comprehensive overview of its postmarket surveillance system and what it feels needs to be done to move it forward.

“FDA’s vision for medical device postmarket surveillance is the creation of a national system that conducts active surveillance in near real-time using routinely collected electronic health information containing unique device identifiers, quickly identifies poorly performing devices, accurately characterizes the real-world clinical benefits and risks of market devices, and facilitates the development of new devices and new uses of existing devices through evidence generation, synthesis, and appraisal,” the report says.”

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