A manufacturer confirms a serious injury linked to a software error in their device. What is the best recommendation for the regulatory professional regarding communication with authorities?

The best recommendation for communication with authorities in this scenario focuses on transparency and timely action, particularly in response to a serious injury linked to a software error in the device. Discussing the incident with the authorities ensures compliance with regulatory reporting obligations, which often require prompt notification of any serious incidents associated with a medical device. This is crucial for maintaining safety and efficacy standards in medical devices.

Sending an advisory letter to each customer is also key because it communicates the potential risks associated with the device, ensuring that users are made aware of the serious injury and any necessary precautions they should take. This proactive communication helps protect patients and allows for timely mitigation measures to be implemented, thereby fostering trust and transparency between the manufacturer, authorities, and customers.

In contrast, completing a product recall may be premature without a thorough assessment of the extent and impact of the software error, while completing a corrective action following just the manufacturer’s procedures might not satisfy regulatory requirements for external notification and could delay necessary actions that ensure patient safety. Discussing the incident with authorities and clarifying the situation is essential for regulatory compliance and responsible medical device management.