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

The first step a regulatory professional should take when a company wants to expand labeling to include a new indication is to contact the review division to determine if a 510(k) or PMA should be prepared. This action is crucial because it helps the professional understand the specific regulatory pathway that the new indication will require, which can vary based on the nature of the change being proposed. The review division has in-depth knowledge of the regulatory requirements and can guide whether the company needs to submit a premarket notification (510(k)), a premarket approval (PMA), or potentially another regulatory submission altogether.

This initial consultation helps in assessing the classification of the device, the requirements for evidence of safety and effectiveness, and ultimately helps streamline the process for the company. It ensures that the regulatory professional has clear guidance from the FDA, which is essential in making informed decisions about the subsequent steps and documentation needed for compliance with regulatory standards.