DICOM and FDA - DICOM

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Thread: DICOM and FDA

  1. DICOM and FDA

    Is there any guideline form the FDA which says that DICOM is the
    preferred method of sending images to the agency for a submission? Do
    they accept compressed images such as jpeg?


  2. Re: DICOM and FDA

    jeffcoh@gmail.com wrote:
    > Is there any guideline form the FDA which says that DICOM is the
    > preferred method of sending images to the agency for a submission? Do
    > they accept compressed images such as jpeg?


    Submission for what purpose ?

    David


  3. Re: DICOM and FDA

    jeffcoh@gmail.com wrote:
    > Is there any guideline form the FDA which says that DICOM is the
    > preferred method of sending images to the agency for a submission? Do
    > they accept compressed images such as jpeg?


    What kind of submission are you talking about? Typically what you see
    on this forum are questions about getting FDA clearance for DICOM or
    medical imaging devices to be used in clinical processes. Normally
    submitting imaging data, DICOM or otherwise, would not be part of that
    process.

    For clinical drug trials, the data submission to the FDA would not
    normally include the image data. Rather, it would include the
    information such as measurements and conclusions extracted tests
    performed during the clinical trial. There is a format called the Study
    Tabulation Data Model (SDTM) which is currently being piloted for
    submissions. SAS transport files and PDF files have also been formats
    which the FDA has accepted for submission data. That said, the FDA has
    indicated in recent years that they reserve the right to be able to
    inspect any of the raw data which has been the input to extracting
    clinical trial measurements. The submitter is expected to maintain the
    "raw data" in the form in which it was received from the clinical trial
    site. When imaging data has been the input, the submitter will very
    often have received it in DICOM format and it will therefore be
    provided to the FDA in DICOM format.

    Another process which is ongoing. An organization called the clinical
    data interchange standards consortium defines standards for clinical
    trial submissions. SDTM is their creature (with contribution from the
    FDA). The SDTM format includes a digital format for including ekg/ecg
    data directly in the submission (and in a format which is different
    from the dicom waveform). CDISC is currently working on a new domain
    for the SDTM submission format. It will likely include aspects from the
    DICOM data model, but at this point I wouldn't count on it "being"
    DICOM.


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