Which aspect does the summary of safety and effectiveness NOT typically cover?

The summary of safety and effectiveness primarily focuses on presenting data related to the clinical trial results, risk assessments, and device performance. It aims to offer a comprehensive overview of how well a medical device performs and the associated risks based on scientific evidence gathered during development and clinical evaluations.

Clinical trial results are crucial as they provide direct evidence of the device's safety and efficacy in human subjects. Risk assessment documents the potential hazards related to the device and the measures taken to mitigate these risks, while device performance evaluates how the device functions or meets its intended purpose.

Market analysis, on the other hand, is generally excluded from the summary of safety and effectiveness. This is because market analysis is more concerned with economic aspects such as market needs, competitive landscape, and potential market share rather than the clinical and safety data that underpin regulatory submissions. Such information may be useful for commercial strategies but does not directly relate to the clinical safety and effectiveness of the device.