The FDA has released a statement of vision laying out ways it hopes to monitor and report on the safety and effectiveness of medical devices already in use by patients. The agency’s Center for Devices and Radiological Health released the publication Sept. 6, just a few days prior to a series of public meetings and workshops it has scheduled on the subject this week.
The publication, “Strengthening Our National System for Medical Device Postmarket Surveillance,” described the creation of a nationwide system conducting active surveillance in near real-time using routinely collected electronic health information containing unique device identifiers (UDIs).
The system would work to quickly identify poorly performing devices, accurately characterize the real-world clinical benefits and risks of marketed devices and “facilitate the development of new devices and new uses of existing devices through evidence generation, synthesis and appraisal,” according to the FDA.
The system would leverage privacy-protected distributed data systems and common data standards. It would augment, rather than replace, existing surveillance systems such as MedSun and Medical Device Reporting (MDR), said the agency.
The publication outlines four steps that the FDA deems necessary to strengthening postmarket surveillance of medical devices:
- Establish a unique device identification (UDI) system and promote its incorporation into electronic health information;
- Promote the development of national and international device registries for selected products;
- Modernize adverse event reporting and analysis; and
- Develop and use new methods for evidence generation, synthesis and appraisal.
“Medical device product evaluation presents unique challenges compared to drugs and biologics, related to the greater diversity and complexity of medical devices, and the rapid technological advances and iterative nature of medical device product development,” said the FDA. “While we strive to permit marketing of only those devices with a favorable benefit-risk profile, even a thorough premarket product evaluation can leave some unanswered questions about a medical device’s performance and associated clinical benefits and risks.”