Recently the FDA issued a report that called for the strengthening the national system for medical device post market surveillance. The areas it’s focusing on for changes are:
1. Establishing a unique device identification system and promoting its incorporation into electronic health information system.
2. Promotion of the development of national and international device registries for selected products.
3. Modernization of adverse event reporting and analysis by:
3.1 developing automated adverse event reporting systems
3.2 increasing the number of MDR’s received electronically
3.3 developing a mobile application for adverse event reporting
3.4 modernizing the medical device adverse event database 3.5 rapidly identifying safety signals
4. Development and use of new methods for evidence generation, synthesis and appraisal in the areas of:
4.1 quantitative decision analysis to evaluate benefits and risks
4.2 evidence assessment by combining data from diverse data sources
4.3 automated signal detection
4.4 refinement of processes for signal detection and management
All of these are significant changes that will impact the level of activity and should be inputs to updates to the quality systems for all FDA regulated industry.
