In the context of human factors studies, what does FDA require for demonstrating safety and efficacy?

In the context of human factors (HF) studies, the FDA requires compelling evidence from HF simulated-use or actual-use validation studies to demonstrate the safety and efficacy of medical devices. This requirement underscores the importance the FDA places on understanding how real users interact with a device, including their capabilities, limitations, and the potential for human error.

The rationale for this requirement is rooted in ensuring that devices are not only designed effectively but also that they perform safely and as intended in the hands of end users. Gathering data through simulated or actual use provides insight into user interactions, identifying any risks that may not be apparent through theoretical assessments alone. This practical testing helps in validating that the device can be used without causing harm and meets the claimed efficacy.

The other options do not align with FDA expectations for human factors studies. A risk-based rationale justifying the absence of HF studies does not provide the necessary evidence; solely theoretical considerations fail to capture the realities of user interaction; and relying on previous marketing data from similar products might not accurately reflect the specific device's safety and efficacy in current contexts. Therefore, the requirement for evidence from HF studies is pivotal in ensuring that devices are user-friendly and safe when utilized as intended.