For which of the following might a manufacturer be typically required to conduct post-market surveillance?

A manufacturer is typically required to conduct post-market surveillance for devices associated with significant adverse events. This requirement arises from the need to monitor the safety and effectiveness of medical devices once they are on the market. Significant adverse events could indicate serious safety concerns that necessitate further investigation. By implementing post-market surveillance, manufacturers can systematically collect and analyze data about the performance of their devices, helping to identify trends that may not have been evident during pre-market testing.

This vigilance aids in ensuring ongoing compliance with regulatory standards and helps protect patient safety. The collection of such data can lead to necessary updates, modifications, or even recalls of devices if issues are detected. In contrast, devices without adverse events, off-label uses, or those with minimal market penetration may not demonstrate the same level of risk or concern that would trigger extensive post-market monitoring.