HF testing / Summative evaluation for MDDS class I necessary?

[Tilly]

Hi all,

As I'm new in the field of class I products I'd like to ask your opinion on:
Does a >medical device data system class I exempt< need a human factors Validation as summative evaluation?

In IEC 62366-1, it's written that "... a manufacturer shall perform a summative evaluation of each hazard-related use scenario selected ...".
In case, there is no scenario where a use error could lead to serious harm has a scenario with related risk of severity marginal to be included instead?
If there's no unacceptable risk identified, does a summative evaluation to be performed anyway to prove that the device is effective for the intended users, uses and use environments?
Or is a usability assessment sufficient?

Thanks in advance for your answers.
Tilly

 

[pziemlewicz]

Hi all,

As I'm new in the field of class I products I'd like to ask your opinion on:
Does a >medical device data system class I exempt< need a human factors Validation as summative evaluation?

In IEC 62366-1, it's written that "... a manufacturer shall perform a summative evaluation of each hazard-related use scenario selected ...".
In case, there is no scenario where a use error could lead to serious harm has a scenario with related risk of severity marginal to be included instead?
If there's no unacceptable risk identified, does a summative evaluation to be performed anyway to prove that the device is effective for the intended users, uses and use environments?
Or is a usability assessment sufficient?

Thanks in advance for your answers.
Tilly

For the FDA, if you have done a Task Analysis and concluded that there are no "Critical Tasks," then a summative study is not required. They will ask you to submit the analysis that got you to that conclusion.

Guidance Document Here. https://www.fda.gov/media/80481/download

 

[yodon]

@pziemlewicz - I don't necessarily disagree with the conclusion but I couldn't find anything in the guidance that supports it.

There still may be valid reasons for conducting a study (general usability, the design supports proper use, the IFU is understandable to the user community, etc.) but if there's no risk in use then at least that aspect could be discounted.