Module 18 2021

09/02/2021

Evaluating medical devices in Human Factors and Usability Tests? Performing studies and tests for a New Drug Application:  If the FDA require comparative Human Factors Studies because you are applying with a generic drug device combination product, then they will request a comparative Human Factors Study.

 The Protocol should be reviewed by the FDA prior to starting since they will want to see the Threshold Analysis.  Additionally, the justification of the sample size.  The sample size generally needs to be around 45 participants as a minimum, but is commonly 100-200 participants to justify comparability.  Comparability between the Reference Listed Drug (RLD) drug device combination product and the new product needs to be determined statistically.  In the comparative Human Factors Study, both devices are tested not for safety or design effectiveness but for comparability by measuring the use error rate for each.  Studies can take months to complete!

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Assessing Usability and Performance during development

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Evaluating medical devices in Human Factors and Usability Tests? Performing studies and tests:  If FDA compliance is required, some tests can be

performed globally, but the Summative Human Factors (Validation) Test or the Comparative Human Factors Study for an ANDA must be performed in the USA unless justification is agreed with the FDA to perform elsewhere.  If CE/CA Marking is required, then there is no requirement to test in a specific location.  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.  The regulation is a minimum! There is value in exceeding the requirements to benefit the user!

The Organisation for Professionals in Regulatory Affairs

Assessing Usability and Performance during development

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