Which of the following is NOT true about human factors (HF) validation studies for drug-led combination products?

The statement that is NOT true in the context of human factors (HF) validation studies for drug-led combination products is that a risk-based rationale to waive the HF validation study is acceptable.

Human factors validation studies are crucial in ensuring that combination products are designed in a way that is safe and effective for end-users—typically patients and healthcare providers. The FDA emphasizes the importance of actual-use validation studies because these studies help to evaluate how users interact with the product in real-world conditions, identifying potential use-related risks.

Options indicating that HF validation studies are optional or that the FDA does not require them outside of simulations do not accurately reflect the regulatory requirements. Likewise, the requirement for actual-use validation studies for marketing authorization underscores that these studies are a necessary part of the evaluation process and cannot simply be waived based on a risk-based rationale. This reflects the FDA’s commitment to patient safety and the effectiveness of drug-led combination products through thorough validation.