As the Director of Regulatory Affairs at a contract sterilizer, what should you do if you find no device listing forms for sterilized devices?

In the scenario where no device listing forms for sterilized devices can be found, prioritizing appropriate and responsible action is essential. The correct course of action involves reporting the issue to senior management for guidance. This is appropriate for several reasons.

First, senior management typically has a broader perspective on the regulatory strategies and organizational policies in place. They may already have established protocols for handling such issues, ensuring compliance with regulations. Moreover, regulatory affairs is critical in the medical device industry, and a lack of device listings can indicate potential compliance issues that need to be addressed at a higher level.

Additionally, regulatory bodies, such as the FDA, require accurate and current device listing information, and failing to address this gap could lead to consequences, including fines or disruption of operations. Therefore, by engaging senior management, you create an opportunity for collaboration, ensuring that the situation is addressed strategically and effectively.

It's important to proactively manage regulatory compliance rather than assuming the situation is not a concern, as this could lead to significant implications for the business.