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 Form Fda 3500a * 2019

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hi everybody today we're going to talk about the use related risk analysis or Ura and If This Acronym sounds completely new to you you can guess who might have created it uh the FDA one of the lovers of acronyms um little joke that was told to me a long time ago was um do you know what a TLA is TLA is the acronym for three-letter acronym any organiz a that creates an acronym for acronyms they're going to create an acronym for just about everything you want so use related risk analysis we have an acronym it's a four-letter acronym use related risk analysis is ur and the FDA wants you to include that in a 5 case Mission or jovo to document your risk analysis for use related risks um for the human factor study that you're going to be doing but a lot of companies use a very logical assumption that hey we can submit this um in other formats we could use a use FMEA or we could use um an application FMEA or we could use some other format that would be in anothe

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