Which of the following is NOT a typical consideration for FDA approval of a device?

The reason the manufacturer's marketing strategies are not a typical consideration for FDA approval of a device is that the FDA's primary focus is on the safety and effectiveness of medical devices rather than commercial aspects. The approval process evaluates whether a device is safe for use and performs as intended based on scientific evidence, including clinical trial results, total benefits versus risks, and long-term safety data.

Clinical trial results are crucial because they provide empirical data about a device’s safety and effectiveness in human subjects. The evaluation of total benefits versus risks is essential as it helps determine whether the advantages of a medical device outweigh any potential hazards. Long-term safety data is also necessary for assessing how a device performs over time and identifying any emerging safety concerns that can arise with prolonged use. Therefore, the FDA's considerations revolve around the technical and clinical aspects of the device rather than how it will be marketed.