How the FDA will Create an Integrated National Postmarket Surveillance System
- Establish a medical device postmarket surveillance system planning board
The FDA intends to establish a medical device postmarket surveillance system planning board that includes representatives from the medical device industry, health care provider community, medical professional societies, patient and consumer groups, third-party payers, hospitals and other health care facilities, health care data holders, government agencies, and other relevant stakeholders. The public will have an opportunity to comment on recommendations from the planning board before a decision is made to implement them.
- Establish a UDI system and promote its incorporation into electronic health information
As directed by Congress, FDA is establishing a unique device identification (UDI) system. The UDI system will provide a standard and unambiguous way to identify devices and document device use in electronic health information systems (EHIs), clinical information systems and claims data sources and registries. Doing this will potentially make vast quantities of previously untapped clinical information available to assess the benefits and risks of medical devices and more meaningfully and efficiently link data sources.
- Promote the development of national and international device registries for selected products
A registry is a system that collects and maintains structured records on a specific disease, condition, procedure, or medical product for a specified time period and population. Registries play a unique and prominent role in medical device surveillance because they can provide additional detailed information about patients, procedures, and devices not routinely collected by electronic health records, administrative or claims data. Targeted registry efforts will be based on wide stakeholder input and support, focusing on selected areas of high importance as reflected by a large public health need, patient exposure, uncertain long-term or real-world device performance, or societal cost.
- Modernize adverse event reporting and analysis
The FDA monitors postmarket device-related adverse events and product problems through both voluntary and mandatory reporting to detect signals of potential public health concern. Because of the limitations of spontaneous reporting systems, modernization of adverse event reporting and analysis is a key requirement of a comprehensive medical device postmarket surveillance system. Several ongoing or proposed activities will significantly enhance our surveillance capabilities.
- Develop and use new methods for evidence generation, synthesis, and appraisal
In 2010, CDRH launched the Medical Device Epidemiology Network (MDEpiNet), a collaborative initiative motivated by the need to develop and apply innovative methodological strategies and develop global infrastructure to address gaps in studying medical devices through public-private partnerships with multiple stakeholders such as academia, professional societies, clinical communities, industry, other government agencies, and patients. The development and application of novel techniques to collect, analyze, synthesize, and communicate knowledge about medical devices potentially reduces the burden and cost of postmarket surveillance, facilitates the premarket development and evaluation of new products, and improves the timeliness, quality and efficiency of postmarket decision-making by the FDA, the medical device industry, health care professionals, and patients.
Please see the Summary of 2013 Planned FDA Actions on postmarket surveillance for more information on actions related to the items above.