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FSCA categorisation

  1. Click on the FSCA Categorisation section from the menu on the left:

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  2. Fill in the fields under IMDRF Medical Device problem codes (Annex A):

    FSCA_Step5_2.png

  3. If you answered Yes to the first question, you need to provide an IMDRF code from the list:

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  4. Similarly to the IMDRF Medical device problem codes section, complete the IMDRF Cause Investigation section by selecting Yes or No from the drop-down list in each field:

    FSCA_Step5_4.png
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  5. If you answered Yes, you need to provide an entry from the list appearing below the question:

    FSCA_Step5_5.png

  6. Similarly, complete the Hazard section by selecting Yes or No from the drop-down list in each field:

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  7. If you answered Yes, you need to provide a code from the list appearing below the question:

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  8. You have the option to also fill in the IMDRF Component codes section in a similar way as the previous sections:

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  9. If you answered Yes, you need to provide a code from the list appearing below the question:

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