USA – Defining critical tasks for human factors validation tests of combination products

There are some differences in how the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), focused on drug and combination products, and Center for Devices and Radiological Health (CDRH), focused on other medical devices, treat the definition of critical tasks for human factors (HF) validation tests.

As defined by CDER’s draft human factors engineering (HFE) guidance, Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development (February 2016), “critical tasks are user tasks that, if performed incorrectly or not performed at all, would or could cause harm to the patient or user, where harm is defined to include compromised medical care.”…