Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear Community,

"If the results of human factors validation testing include use errors on critical tasks or participant feedback indicating difficulty with critical tasks, stating in a premarket submission that you mitigated the risks by modifying the instructions for use or some other element of labeling is not acceptable unless you provide additional test data demonstrating that the modified elements were effective in reducing the risks to acceptable levels." - FDA Guidance (Applying Human Factors and Usability Engineering to Medical Devices)

From your experience, could you please help me understand whether this implies that the summative testing must be repeated with recruited participants (quite costly)? Is there any other acceptable way of validating the mitigations?
 
I appreciate your time and help.

Best regards

Anonymous,

Generally, yes, this requires 're-validation' (i.e. another Human Factors study) to address the changes made in response to the original results. However, it does not have to be a wholesale repeat of the initial study - instead, it could focus on only the relevant portions affected (or potentially affected) by the changes. When coupled with the original results, it could provide support for design validation of the overall product (assuming generally positive data). This could help reduce the duration/cost of the second study (though possibly not size, unless only specific user group(s) were affected in which case those could be reduced).

Feel free to reach out directly if you require more specific advice.

------------------------------
Jonathan Amaya-Hodges
Director, Technical Services
Sharon MA
United States
------------------------------

Original Message:
Sent: 28-Jul-2022 04:26
From: Anonymous Member
Subject: Usability Summative Testing / Re-Testing

This message was posted by a user wishing to remain anonymous

Dear Community,

"If the results of human factors validation testing include use errors on critical tasks or participant feedback indicating difficulty with critical tasks, stating in a premarket submission that you mitigated the risks by modifying the instructions for use or some other element of labeling is not acceptable unless you provide additional test data demonstrating that the modified elements were effective in reducing the risks to acceptable levels." - FDA Guidance (Applying Human Factors and Usability Engineering to Medical Devices)

From your experience, could you please help me understand whether this implies that the summative testing must be repeated with recruited participants (quite costly)? Is there any other acceptable way of validating the mitigations?

I appreciate your time and help.

Best regards

Dear Anon:

Not knowing what device type you are inquiring about-here below are more FDA Guidance that may possibly help you with repeat testing from human factors use failures including design or labeling.

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------------------------------
Ram Balani
CEO
FDASmart Inc. /eSTARHelper LLC www.estarhelper.com
Amawalk , New York
rbalani@fdasmart.com
2019130558
https://tinyurl.com/2wkxp69y
on US FDA eSTAR for 510(K)
------------------------------

Original Message:
Sent: 29-Jul-2022 06:35
From: Jonathan Amaya-Hodges
Subject: Usability Summative Testing / Re-Testing

Anonymous,

Generally, yes, this requires 're-validation' (i.e. another Human Factors study) to address the changes made in response to the original results. However, it does not have to be a wholesale repeat of the initial study - instead, it could focus on only the relevant portions affected (or potentially affected) by the changes. When coupled with the original results, it could provide support for design validation of the overall product (assuming generally positive data). This could help reduce the duration/cost of the second study (though possibly not size, unless only specific user group(s) were affected in which case those could be reduced).

Feel free to reach out directly if you require more specific advice.

------------------------------
Jonathan Amaya-Hodges
Director, Technical Services
Sharon MA
United States

Original Message:
Sent: 28-Jul-2022 04:26
From: Anonymous Member
Subject: Usability Summative Testing / Re-Testing

This message was posted by a user wishing to remain anonymous

Dear Community,

"If the results of human factors validation testing include use errors on critical tasks or participant feedback indicating difficulty with critical tasks, stating in a premarket submission that you mitigated the risks by modifying the instructions for use or some other element of labeling is not acceptable unless you provide additional test data demonstrating that the modified elements were effective in reducing the risks to acceptable levels." - FDA Guidance (Applying Human Factors and Usability Engineering to Medical Devices)

From your experience, could you please help me understand whether this implies that the summative testing must be repeated with recruited participants (quite costly)? Is there any other acceptable way of validating the mitigations?

I appreciate your time and help.

Best regards

The first issue is the wording of the FDA guidance document. The manufacturer does not "mitigate" risks but reduces them. Reduce has the sense of preventing the harm with mitigate has the sense of working on the effect of a harm on the patient or user. ISO 14971:2019 does not contain the word mitigate.

The paragraph deals with critical tasks. If you find a problem, then you need to fix it. However, there is still the issue of knowing the fix works. This means retesting.

While the paragraph says to provide additional test data, the presumption is to run part of the summative evaluation. It does not need to be the full set and could have a different sample size. For example, if one category of users experience the problem, then you probably don't need representatives from the other categories. Write a simple test plan for the retest.

Lastly, FDA does not care about your cost to acquire data, only that you provide good data.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 28-Jul-2022 04:26
From: Anonymous Member
Subject: Usability Summative Testing / Re-Testing

This message was posted by a user wishing to remain anonymous

Dear Community,

"If the results of human factors validation testing include use errors on critical tasks or participant feedback indicating difficulty with critical tasks, stating in a premarket submission that you mitigated the risks by modifying the instructions for use or some other element of labeling is not acceptable unless you provide additional test data demonstrating that the modified elements were effective in reducing the risks to acceptable levels." - FDA Guidance (Applying Human Factors and Usability Engineering to Medical Devices)

From your experience, could you please help me understand whether this implies that the summative testing must be repeated with recruited participants (quite costly)? Is there any other acceptable way of validating the mitigations?

I appreciate your time and help.

Best regards