Posted By
Kasi Gurung
21-Mar-2019 13:51
Found In
Egroup:
Regulatory Open Forum
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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 ...
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