What can be the impact of failing to conduct human factors studies as mandated by the FDA?

Failing to conduct human factors studies as mandated by the FDA can lead to potential delays in drug approval. Human factors studies are critical in evaluating how users interact with a product, particularly regarding safety and efficacy. These studies help identify any issues that could arise during use, leading to modifications that ensure the drug/device is safe and effective for its intended population. If a company does not conduct these studies, the FDA may require additional data or modifications to the product before granting approval. This can extend the approval timeline significantly, as the agency might wait for these essential assessments to be completed before moving forward with the review process. Such delays can have significant commercial implications, impacting the overall market entry of a product.

On the other hand, the other choices do not accurately reflect the consequences of not conducting human factors studies. A stronger market position, improved user experience, and reduced production costs may be desirable outcomes, but they are unlikely to result from skipping necessary regulatory evaluations, especially those aimed at ensuring user safety and product effectiveness.