Since the late 1990s, FDA has expected Class II and III medical device manufacturers to apply human factors engineering (HFE) comprehensively to help reduce the chance of harm due to use errors. In 2016, FDA updated its HFE guidance to industry, specifying that submissions should include an HFE Report if the associated device requires users to perform safety-critical tasks.
In this 60-minute webinar held live on 13th and 26th September 2017, two of UL’s HFE experts have (1) reviewed the basics of preparing an HFE report, (2) discussed the lessons they have learned writing and defending them on behalf of clients, and (3) answered audience member questions. The presenters also discussed the importance of documenting how a use-related risk analysis helped drive the device’s user interface design and served as the basis for validation testing. They offered advice on how to support a claim that a device is safe for use despite the occurrence of interaction problems (e.g., use errors, close calls, difficulties) during a summative usability test.
The presenters discussed how to put a device’s residual, use-related risk into proper perspective in relation to its benefits. They also commented on the benefits of writing a well-organized, concise, and illustrated document that eschews “spin” in favor of objective reporting. You can learn the importance of starting the HFE reporting effort early and committing sufficient resources to the task to produce a compelling end-product that could spell the difference between device approval and rejection.
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Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. Read more about this.