1. Hello and Welcome to The Quality Forum Online...Continuing in the spirit of People Helping People !
    Dismiss Notice
Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

CTD only for pharmaceutical products or also for IVD required?

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

  1. Daliane

    Daliane Member

    Joined:
    Oct 30, 2015
    Messages:
    6
    Likes Received:
    0
    Trophy Points:
    1
    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
     
  2. Ronen E

    Ronen E Well-Known Member

    Joined:
    Jul 31, 2015
    Messages:
    133
    Likes Received:
    70
    Trophy Points:
    27
    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.
     
  3. Vintage Goose

    Vintage Goose Active Member

    Joined:
    Oct 6, 2015
    Messages:
    70
    Likes Received:
    37
    Trophy Points:
    17
    Hi, are they confusing it with a CSDT (Common Submission Dossier Template) which will be required for IVDs in ASEAN countries?
    Chris
     

Share This Page