What should be included in a Field Safety Notice (FSN)?

A Field Safety Notice (FSN) is a crucial communication tool that is issued by manufacturers of medical devices when there are safety issues that could potentially affect patient or user safety. Its primary purpose is to inform users, healthcare professionals, and regulatory authorities about specific risks associated with the device and to provide instructions for corrective actions when necessary.

Including advice on safety issues or corrective actions ensures that all relevant parties are made aware of any potential hazards and can take the appropriate measures to mitigate risks. This information is vital for ensuring patient safety and compliance with regulatory requirements, thereby protecting public health.

The other options do not serve the essential purpose of an FSN. For instance, marketing strategies and product sales data are focused on business aspects and do not address safety concerns or actions. Similarly, while technical specifications might be relevant in some contexts, they do not directly inform recipients about safety issues or necessary corrective measures that are the core intent of an FSN.