If the FDA sends a warning letter regarding the mislabeling of a medical device, who should the regulatory affairs professional contact first?

The primary role of a regulatory affairs professional when responding to an FDA warning letter, especially regarding issues like mislabeling of a medical device, is to initiate contact with the most appropriate and immediate resource within the FDA. Contacting the Compliance Branch in their district is crucial because this branch is directly responsible for overseeing compliance issues and addressing concerns related to specific products and manufacturers within their jurisdiction.

The Compliance Branch serves as the first point of contact for such regulatory matters, managing the FDA’s interactions regarding compliance and enforcement actions, including warning letters. They have the expertise and authority to provide guidance on how to appropriately address the concerns stated in the warning letter and the necessary steps for corrective actions.

While other options like the Orthopedic Branch Chief or the DSMICA could be relevant in certain contexts, they may not be the most immediate resource for addressing a compliance issue directly stemming from a warning letter. The CDRH Ombudsman, on the other hand, typically provides assistance in resolving disputes or questions regarding CDRH processes but is not the first point of contact for compliance issues. Thus, reaching out to the Compliance Branch ensures that the response is handled efficiently and directed to the appropriate channel within the FDA.