If a company wishes to expand labeling to include a new indication, what should the regulatory professional do FIRST?

When a company seeks to expand labeling to include a new indication, the first step for the regulatory professional is to contact the review division to determine if a 510(k) or a Premarket Approval (PMA) should be prepared. This initial contact is crucial because it helps clarify the regulatory pathway based on the type of indication being proposed and the device's classification. Understanding whether the new indication can be supported through a 510(k) process or if it necessitates a more stringent PMA submission is essential for ensuring compliance with FDA requirements.

The reason for prioritizing this action is that it sets the foundation for the entire submission process. Different indications may not only have varying levels of evidence required but may also impact the timeline and resources allocated for the regulatory filing. By understanding the appropriate path early on, the regulatory professional can effectively design the subsequent documentation and strategy, and align all subsequent actions with FDA expectations.

In this context, while other options may involve steps in the process, none of them prioritize the essential first action of engaging with the regulatory authority to clarify the required submission pathway based on the new indication being considered.