Module 14: Design Development and Certification of Medical Devices

Evaluating medical devices in Human Factors and Usability Studies

Performing studies and tests: ❑ If FDA compliance is required, some tests can be performed globally, but the Summative Human Factors (Validation) Test must be performed in the USA. The same for China. ❑ If CE Marking is required, then there is no requirement to test in a specific location. ❑ Sample size requirements are defined in the FDA and NMPA Human Factors Guidances and the MHRA Human Factors Guidance but NOT in IEC 62366-1. This is because it links to ISO 14971 – a risk-based approach. IEC 62366-2 does reflect the FDA requirements. ❑ The number of Formative Usability Studies should be based upon the risk of the drug delivery device and the amount of innovation it includes. ❑ More Formative Studies is better to de-risk the Summative Human Factors Test. ❑ Formative Studies should always be performed before Comparative Use Human Factors Studies (for ANDA devices).

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