What is the main purpose of post-market surveillance?

The main purpose of post-market surveillance is to monitor the safety and effectiveness of a device after it has been marketed. This is crucial for ensuring that any adverse effects or complications that arise during actual use in the general population are identified and addressed. Regulatory bodies, such as the FDA, require manufacturers to actively collect and analyze data on the performance of their devices once they are on the market. This ongoing assessment helps to confirm that the device continues to meet its intended use and identifies any long-term effects that may not have been apparent during clinical trials. By effectively conducting post-market surveillance, manufacturers can take necessary actions, such as issuing recalls or updating labeling, to safeguard public health.