How Does The FDA's New Usability Guidance Affect Your 510k submissions?
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Task Analysis Webinar (Oct.17) - for medical device human factors and usability engineering
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Hello everyone, my name is matthew walker with medical device academy and this is the human factors tip of the week for the week of September 3rd. Usability requirements for the FDA can be confusing and that isn’t just for 510(k)’s with established predicate devices. It gets even more complicated with de novo submissions. The FDA actually has a dedicated Human Factors Team at the Center for Devices and Radiological Health. On their bio page you can see that the FDA views usability as part of you
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The FDA has a great example of what I refer to as 'ease of use' at 'point of use'. If you look at Section 6.2 of their 2016 Usability Guidance Document, they suggest performing essentially a literature search to identify known use related issues for medical devices that are similar to the one that you are developing. Then, they provide seven examples such as the MAUDE and Recall databases, but they provide them as clickable hyperlinks that will bring you straight to the database in question. Thi
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