In this series of posts, we’re taking a look at the recently published final version of CDRH’s guidance “Applying Human Factors and Usability Engineering to Medical Devices”.
The document, published on 3 February, is the result of nearly 5 years of consultation with industry since releasing a draft guidance back in 2011.
We have covered a lot of ground already. In the first 3 parts, we heard about four of this list of the key topics covered by the Center:
- Human Factors Engineering process
- Risk Management and Human Factors
- Design Verification
- Summative Human Factors testing
- Changes to products already on the market
- Human Factors Engineering Summary report
In part 4, we’ll look at the Human Factors Engineering Summary report and submission of your HFE data. You may then want to think about how this may impact what you’re either already doing, or plan to do.
Changes to products already on the market
You may be wondering how this relates to devices that are already on the market? The agency has provided some guidance to help you understand when modifications to a device mean that it should undergo validation testing. The need for additional human factors validation testing should be based on risk management planning and risk analysis for the modified User Interface or Tasks, to determine the scope and nature of testing required and should focus on those hazard-related use scenarios and critical tasks. The test may, however, be limited to assessment of those aspects of users’ interactions and tasks that have only been affected by the design modifications.
The agency also recommend that for any further human factors validation testing consideration should be given to user’s comparison of the design modification to the previous design.
Human Factors Engineering Summary report
It’s often seen as the culmination of your HFE programme.
Expectations for content of the report have expanded, to require far greater information about analysis and elimination/reduction of risks and hazards associated with use of the device, critical tasks and use scenarios. Far greater detail is needed about the validation study, discussing test environments, training correspondence to real-life, data collection methods, test results, feedback, analysis of use errors, difficulties, root causes of problems and implications for risk elimination/reduction.
The Center are proposing to require submission of HFE data with your PMA or 510-K, for those devices where users performing tasks incorrectly or failing to perform tasks could result in serious harm. There’s a separately issued, draft, guidance that outlines current thinking on which devices would need this as a matter of course, which may well change between now and the final version of that document.
However, the agency has not removed the expectation that a human factors programme is present as an integral part of a robust design control system.
So you still have to do it, you just may not always need to include an HFE Summary report in your submission dossier.
When is the guidance effective?
You will have some time to assimilate the requirements…
A whole month, as they go live on 3 April 2016.
How will these changes will affect your product development?
What impact they will have upon your Human Factors Engineering programme?
Get in touch today to discuss how you can best navigate the changes and emerge with a Human Factors programme that is “just right”.