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Hello, Anyone interested to form a study group for upcoming Devices exam? Thanks ------------------------------ Kasi Gurung Germantown TN United States ------------------------------ ------------------------------------------- Original Message: Sent: 11-Jul-2019 14:58 From: Anonymous Member ...

Hi Karen, I am new to this forum and not an expert, but I would start with 62304, section 5.1.  Thanks ------------------------------ Kasi Gurung Germantown TN United States ------------------------------ ------------------------------------------- Original Message: Sent: 09-May-2019 12:52 ...

You can create a simple form in word, with your document header, software/device name, version or any other identifier. Then you can copy the two tables on pages 6 and 7 of the attached FDA guidance document, and add a Yes/No column to the right. The decision rules are printed in bold. At the bottom ...

​ Hello I am new to this forum. Glen has responded to the predicate rule requirements. So this response is about the debate that you are having. I think 11.1 (b) answers your question/debate. Signing an already signed document does not give much information. We use our internal review form to assess ...