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  • 1.  FDA ECG data requirements

    This message was posted by a user wishing to remain anonymous
    Posted 31-Jan-2022 13:51
    This message was posted by a user wishing to remain anonymous

    Hello,

    A company is developing a SaMD for evaluation of ECG data. There are several questions coming up about the ECG data used to evaluate the effectiveness of the software. Can anyone help with the below questions? The questions are geared for an FDA submission.
    1. Do cardiologists need to annotate the ECG data or can it be any trained personnel?
    2. How many blinded cardiologist/trained personnel are required to annotate the data?
    3. Are there requirements for where this data comes from? (I.e. US vs other jurisdictions)?


  • 2.  RE: FDA ECG data requirements

    This message was posted by a user wishing to remain anonymous
    Posted 09-Feb-2022 09:24
    This message was posted by a user wishing to remain anonymous

    Can anyone help with this? I have found some guidance documents, but they are all for pharmaceutical, none for medical devices.
    Original Message


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