This message was posted by a user wishing to remain anonymous

Hi all,

Class II medical device, is Human Factors Testing a requirement or suggestion for Design Controls?  The device is sold into Canada, US and EU.

I have reviewed the FDA's draft guidance document, in order to inform medical device manufacturers which device types should have human factors data included in premarket submissions, and our device is not listed or included.  In addition, the analysis of risk indicates that users performing tasks incorrectly or failing to perform tasks does not result in serious harm.

Therefore I have the following questions:
1. Is Human Factors a requirement or suggestion for Design controls?  Meaning, does it need to specifically state "Human Factors" in our design control procedures?

Human factors testing is part of design validation, which is part of design control. However, you may provide a justification as to why  it is not required for FDA.  I cannot speak for Health Canada nor EU.   However, human factors / usability testing may be required under the EU MDR.  It'd be helpful for somebody to confirm.

------------------------------
Karen Zhou
------------------------------

Original Message:
Sent: 09-Jan-2020 21:31
From: Anonymous Member
Subject: Human Factors Testing

This message was posted by a user wishing to remain anonymous

Hi all,

Class II medical device, is Human Factors Testing a requirement or suggestion for Design Controls?  The device is sold into Canada, US and EU.

I have reviewed the FDA's draft guidance document, in order to inform medical device manufacturers which device types should have human factors data included in premarket submissions, and our device is not listed or included.  In addition, the analysis of risk indicates that users performing tasks incorrectly or failing to perform tasks does not result in serious harm.

Therefore I have the following questions:
1. Is Human Factors a requirement or suggestion for Design controls?  Meaning, does it need to specifically state "Human Factors" in our design control procedures?

Usability requirements are specifically mentioned in ISO 13485:2016, as design​ input (Clause 7.3.3), and to be taken into account during design and development changes (clause 7.3.9).  EN IEC 62366:2008 is a harmonized standard for the MDD in the European Union and ISO 62366:2015 is a recognized standard in Canada.
In the General Safety and Performance requirements (Annex I of the MDR) reference is made in several requirements to take account of 'ergonomic features'.
So yes, usability is to be taken into account during 'design control' in the EU and Canada.

------------------------------
Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs
Arnhem
Netherlands
------------------------------

Original Message:
Sent: 10-Jan-2020 09:51
From: Karen Zhou
Subject: Human Factors Testing

Human factors testing is part of design validation, which is part of design control. However, you may provide a justification as to why  it is not required for FDA.  I cannot speak for Health Canada nor EU.   However, human factors / usability testing may be required under the EU MDR.  It'd be helpful for somebody to confirm.

------------------------------
Karen Zhou

Original Message:
Sent: 09-Jan-2020 21:31
From: Anonymous Member
Subject: Human Factors Testing

This message was posted by a user wishing to remain anonymous

Hi all,

Class II medical device, is Human Factors Testing a requirement or suggestion for Design Controls?  The device is sold into Canada, US and EU.

I have reviewed the FDA's draft guidance document, in order to inform medical device manufacturers which device types should have human factors data included in premarket submissions, and our device is not listed or included.  In addition, the analysis of risk indicates that users performing tasks incorrectly or failing to perform tasks does not result in serious harm.

Therefore I have the following questions:
1. Is Human Factors a requirement or suggestion for Design controls?  Meaning, does it need to specifically state "Human Factors" in our design control procedures?

This is one of the more explicit HF guidances published by FDA. Consider this along with other data.

Also, check FDA website for exemptions to 510(k) and/or GMP.

Hope it helps.

------------------------------
Adam Atherton
Farragut TN
United States
------------------------------

Original Message:
Sent: 09-Jan-2020 21:31
From: Anonymous Member
Subject: Human Factors Testing

This message was posted by a user wishing to remain anonymous

Hi all,

Class II medical device, is Human Factors Testing a requirement or suggestion for Design Controls?  The device is sold into Canada, US and EU.

I have reviewed the FDA's draft guidance document, in order to inform medical device manufacturers which device types should have human factors data included in premarket submissions, and our device is not listed or included.  In addition, the analysis of risk indicates that users performing tasks incorrectly or failing to perform tasks does not result in serious harm.

Therefore I have the following questions:
1. Is Human Factors a requirement or suggestion for Design controls?  Meaning, does it need to specifically state "Human Factors" in our design control procedures?

Original Message------

This message was posted by a user wishing to remain anonymous

Hi all,

Class II medical device, is Human Factors Testing a requirement or suggestion for Design Controls?  The device is sold into Canada, US and EU.

I have reviewed the FDA's draft guidance document, in order to inform medical device manufacturers which device types should have human factors data included in premarket submissions, and our device is not listed or included.  In addition, the analysis of risk indicates that users performing tasks incorrectly or failing to perform tasks does not result in serious harm.

Therefore I have the following questions:
1. Is Human Factors a requirement or suggestion for Design controls?  Meaning, does it need to specifically state "Human Factors" in our design control procedures?

This message was posted by a user wishing to remain anonymous

If there is a decision that HF testing is not required, where would you suggest this is justified? Which section would you add this to?

Thanks

Original Message:
Sent: 11-Jan-2020 07:48
From: Lee Leichter
Subject: Human Factors Testing

Hi Anon,

 

Consideration of Use Risk is a required part of risk assessment, and therefore of Design Controls.  Determination and Documentation that the use risk is acceptable is a HF Function.  Documentation of these considerations, along with a justification that a Human Factors Validation Study is NOT required, is an HF Exercise.

 

Without knowing the type of device, I cannot advise whether the best path is just to keep these documents in your files or provide the justification as part of your 510(k). You certainly will need to have it part of your technical file for NB review to show compliance with the IEC 62366 standard.

 

Lee Leichter

President

P/L Biomedical

10882 Stonington Avenue

Fort Myers, FL 33913 USA

Office: +1-239-244-1448

Cell: +1-239-994-6488

Email: leichter@plbiomedical.com

 

Original Message------

This message was posted by a user wishing to remain anonymous

Hi all,

Class II medical device, is Human Factors Testing a requirement or suggestion for Design Controls?  The device is sold into Canada, US and EU.

I have reviewed the FDA's draft guidance document, in order to inform medical device manufacturers which device types should have human factors data included in premarket submissions, and our device is not listed or included.  In addition, the analysis of risk indicates that users performing tasks incorrectly or failing to perform tasks does not result in serious harm.

Therefore I have the following questions:
1. Is Human Factors a requirement or suggestion for Design controls?  Meaning, does it need to specifically state "Human Factors" in our design control procedures?

Original Message------

This message was posted by a user wishing to remain anonymous

If there is a decision that HF testing is not required, where would you suggest this is justified? Which section would you add this to?

Thanks

Human Factors is normally part of the testing completed during design validation (DV), and DV is part of Design controls. FDA Guidance ( assuming you are talking about FDA Guidance: List of Highest Priority Devices for Human Factors Review) was created with the purpose to inform medical device manufacturers which device types should have human factors data included in premarket submissions (i.e., for PMA, 510(k)). 

If your device is not listed in this list, and the risk analysis concluded that your device doesn't result in serious harm, why do you still have question about it? I am sorry, just asking because I may not be understanding your question.

In my opinion, even if your Class II device is not listed in FDA Guidance, listed above It is important to complete Human Factors. You always want to make sure that the interaction of people with the device is correct.

------------------------------
Nina Joyce
Bay Village OH
United States
------------------------------

Original Message:
Sent: 09-Jan-2020 21:31
From: Anonymous Member
Subject: Human Factors Testing

This message was posted by a user wishing to remain anonymous

Hi all,

Class II medical device, is Human Factors Testing a requirement or suggestion for Design Controls?  The device is sold into Canada, US and EU.

I have reviewed the FDA's draft guidance document, in order to inform medical device manufacturers which device types should have human factors data included in premarket submissions, and our device is not listed or included.  In addition, the analysis of risk indicates that users performing tasks incorrectly or failing to perform tasks does not result in serious harm.

Therefore I have the following questions:
1. Is Human Factors a requirement or suggestion for Design controls?  Meaning, does it need to specifically state "Human Factors" in our design control procedures?

Is this guidance that you reviewed? 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/list-highest-priority-devices-human-factors-review

HFE is a part of robust design control and a subset of design validation. In fact, it's an integral part of the entire product development life cycle. However, HFE is not always required in a submission. If so, I would not advise submitting to avoid extra questions or competitive discoveries, rather just leave it in your design file. You will need to demonstrate it is not required through a usability assessment. That's where the IEC 62366 and the FDA's guidance on Human Factors come in.
If you perform the assessment (e.g. analyze the intended use, user characteristics, use environment, etc.) and determine there are no use related risks that could cause serious harm, then a study may not be needed but could be requested by the reviewer regardless. 

Good luck!

------------------------------
Jo Huang RAC
Sr. Regulatory Affairs Specialist
Athens TX
United States
------------------------------

Original Message:
Sent: 09-Jan-2020 21:31
From: Anonymous Member
Subject: Human Factors Testing

This message was posted by a user wishing to remain anonymous

Hi all,

Class II medical device, is Human Factors Testing a requirement or suggestion for Design Controls?  The device is sold into Canada, US and EU.

I have reviewed the FDA's draft guidance document, in order to inform medical device manufacturers which device types should have human factors data included in premarket submissions, and our device is not listed or included.  In addition, the analysis of risk indicates that users performing tasks incorrectly or failing to perform tasks does not result in serious harm.

Therefore I have the following questions:
1. Is Human Factors a requirement or suggestion for Design controls?  Meaning, does it need to specifically state "Human Factors" in our design control procedures?