Which statement best defines post-market surveillance?

Which statement best defines post-market surveillance?

• A. Maintaining inventory levels in hospital.
• B. Auditing supplier contracts annually.
• C. Ongoing monitoring of device performance in real-world use to detect issues, inform risk management, and trigger actions.
• D. Initial testing before market release only.

Answer: (C)

Post-market surveillance is the ongoing collection and review of real-world device performance after it has entered the market. It looks for safety issues, evaluates how well the device works in everyday use, and uses that information to manage risk and trigger actions such as recalls, design changes, or updates to labeling and instructions. Real-world data—from adverse event reports, user feedback, and performance registries—helps identify problems that may not appear during pre-market testing and keeps safety current. This differs from pre-market activities, which focus on assessing safety and efficacy before release.

Post-market surveillance is the ongoing collection and review of real-world device performance after it has entered the market. It looks for safety issues, evaluates how well the device works in everyday use, and uses that information to manage risk and trigger actions such as recalls, design changes, or updates to labeling and instructions. Real-world data—from adverse event reports, user feedback, and performance registries—helps identify problems that may not appear during pre-market testing and keeps safety current. This differs from pre-market activities, which focus on assessing safety and efficacy before release.