The U.S. Food and Drug Administration (FDA) has issued a funding announcement to support further development of the National Medical Device Postmarket Surveillance System.
The effort encompasses epidemiologic methodologies and scientific systems to facilitate a comprehensive understanding of medical device performance and clinical outcomes associated with medical device use.
In September 2012, FDA released a report, “Strengthening Our National System for Medical Device Postmarket Surveillance.” This report highlighted the need for FDA to work collaboratively with a broad array of stakeholders to develop the necessary systems and methodologies to facilitate a comprehensive, in-depth understanding of medical device use and associated health outcomes.
Exposure to a medical device can be as complex as a permanent implant to a surgical instrument, to an in vitro diagnostic that never comes into physical contact with a patient, but which plays an important role in guiding medical decision making. Identifying patient exposure to medical devices and relating it to clinical outcomes, especially low-frequency outcomes, is extremely difficult with current systems and methodology.
The FDA Medical Device Epidemiology Network (MDEpiNet) initiative and its evolving partnership infrastructure and capabilities will be vital to the implementation of the National Medical Device Postmarket Surveillance System.
The stated aims of the effort are:
1. To support the implementation of the National Medical Device Postmarket Surveillance System through sustainable multi-stakeholder partnerships.
2. To develop new epidemiologic methodologies or to apply methodologies in new ways to provide a comprehensive understanding of medical device performance in real-world use settings.
3. To develop new systems of data collection and/or analysis to permit prospective active medical device postmarket risk identification, medical device performance, periodic systematic updates of comprehensive evidence syntheses, visual analytics, and other similar efforts to broadly apply complex methodology to diverse data sources that facilitates postmarket surveillance.
4. To develop methodological approaches and/or systems that facilitate the use of postmarket information for regulatory decision making throughout the entire device lifecycle.
5. To support development of and access to high quality data sources that can be used in comprehensive postmarket evaluation of medical device performance and associated outcomes.
It is expected that the infrastructure and methodologies developed through this initiative will not only support FDA’s postmarket surveillance program, but also provide important and timely information to patients, healthcare providers, insurers, and the medical device industry to advance medical device development and improve public health.
Further details are available under Solicitation Number: PAR-13-232. The application deadline is June 24, 2013.
