According to FDA, current postmarket safety actions are hindered by “limitations in the quality, quantity, and timeliness” of available data. The ability to quickly conduct postmarket studies is also limited. The proposed network will use electronic databases and surveillance systems to provide a “seamless, timely flow” of product information while also protecting patient privacy. Data collection, risk identification and analysis, and risk communication would be the main actions of the network.
FDA is holding a two-day public meeting in March to discuss the network. It wants to hear examples from industry groups that have access to “electronic, population-based data sets” that could be used for monitoring postmarket safety. The meeting will also discuss
- Potential obstacles and incentives for developing the network.
- How postmarket device safety data collection can be effectively incorporated into clinical practice work flow at the point of care.
- How electronic health records can be used as a means for data collection related to device safety in the least burdensome manner for clinicians and patients.
- How the network can guarantee the privacy of patient information.
The meeting will seek to identify and fill the current gaps in postmarket product safety data collection and risk processes. Future opportunities, such as collaborations between the public and private sectors to build data collection and risk components for the network, will also be explored.