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CTD only for pharmaceutical products or also for IVD required?

Discussion in 'Medical Devices (21 CFR Part 820)' started by Daliane, Nov 11, 2015.

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  1. Daliane

    Daliane Member

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    Hello everybody,

    our customer wants to export our microarray scanner, which is an IVD, to the US. They state, that for the approval process the CTD is necessary.
    According to my information this is only for pharmaceutical products, since it requires information about dosage form and amount etc.

    Can you please help me with what's going on? Is CTD also necessary for medical products and IVD?

    Appreciate any help

    Thanks
     
    Daliane, Nov 11, 2015
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  2. Ronen E

    Ronen E Well-Known Member

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    Hi Daliane,

    In the USA, if an IVD device meets the Medical Device definition in the FD&C Act, it's generally treated like any other medical device. Search up the applicable Procode (3-letter FDA code) and see exactly what's required for your device.

    Cheers,
    Ronen.
     
    Ronen E, Nov 11, 2015
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  3. Vintage Goose

    Vintage Goose Active Member

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    Hi, are they confusing it with a CSDT (Common Submission Dossier Template) which will be required for IVDs in ASEAN countries?
    Chris
     
    Vintage Goose, Nov 12, 2015
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