Which of the following is NOT required to be prepared by a regulatory affairs professional prior to submitting a PMA to the FDA?

The correct answer is that it is not required for a regulatory affairs professional to prepare criteria for the Medical Device Reporting (MDR) report prior to submitting a Premarket Approval (PMA) application to the FDA. The primary focus during the PMA submission process is on demonstrating the safety and effectiveness of the device based on clinical and preclinical data.

In this context, while understanding MDR reporting requirements is crucial for post-market surveillance and compliance, preparing explicit criteria for the MDR report does not fall under the direct responsibilities inherent to the PMA submission. Instead, the regulatory professional will need to ensure that the PMA includes adequate and appropriate data to support the approval, rather than preemptively creating a framework for reporting adverse events at this stage.

Tasks such as preparing a brief statement of reasons for noncompliance, identifying omissions in PMA content, and reviewing and organizing the data relevant to safety and efficacy are all critical parts of the PMA preparation process, ensuring that the application submitted is comprehensive and adheres strictly to FDA requirements. This structured preparation increases the likelihood of approval by presenting a well-documented case that meets FDA standards.