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Three different clients of mine have recently received 510(k) deficiency letters from the FDA related to human factors. I have heard similar feedback from colleagues that specialize in FDA submissions. The FDA guidance document has not changed since … source: https://www.linkedin.com/groups/2070960/2070960-6260503866601672707 Marked as spam
 Posted by Asked on April 19, 2017 12:00 am
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Jonathan Wacks
The Combination Drug/Device space is getting hammered as well. New Guidance Docs want to see "use error" comparability between branded and generic products, in addition to Summative HF studies. Game Changer.
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Private answer
Diana Downs
I agree with this. However I believe some of these statements maybe directed towards a specific medical device. It is required you provide a justification statement for your reasonings.
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