When filing for PMA of a Class III device, what information is required?

When filing for a Pre-Market Approval (PMA) of a Class III device, a Summary of Studies is crucial as it provides an overview of the clinical investigations that have been conducted to demonstrate the safety and effectiveness of the device. This summary should include details on the study design, methodologies, results, and conclusions drawn from the data collected.

This information is essential because Class III devices are typically high-risk and require rigorous evidence to be approved for marketing. The PMA application must have a comprehensive summary that clearly illustrates how the studies support the claims made regarding the device’s performance.

While other options might contain elements important in different contexts, they do not specifically apply to the PMA requirements for a Class III device. Bioequivalence Information is more relevant to abbreviated PMAs or 510(k) submissions for devices that are similar to already approved products. Electronic CTD Specifications pertain to the format of submissions but do not focus on the specific content required for PMA. Paragraph IV Certification relates to the patent challenges typically associated with generic drug approvals, and is not applicable to Class III device PMAs. Thus, the requirement for a Summary of Studies is fundamental for establishing a persuasive case of safety and effectiveness for the PMA process.