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  • 1.  Diagnostic Test Result Declarations

    This message was posted by a user wishing to remain anonymous
    Posted 27-Oct-2022 15:30
    This message was posted by a user wishing to remain anonymous

    I am looking for some guidance on disclosure or declarations made on the IVD test results output from the IVD instrument.

    1)What disclosures must be included in IVD test results? Are there any mandatory disclosures required to be made? 

    2) What info can/ should be presented on the device vs EMR? 

    3) Any requirements from HIPPA?

    Thank you for you time and responses.


  • 2.  RE: Diagnostic Test Result Declarations

    Posted 28-Oct-2022 05:12
    Good day Anon,

    To answer your questions, it really depends on the IVD test because there can be such variety, how test results are presented, in what environment they are used (lab vs. at home), the answer to your questions will be highly dependent on your the product offering.

    1. There is no standard disclosure nor any regulatory requirement for disclosure or declarations for IVD tests.  It depends on how the test results are presented because some may just be a number for the user (glucose test) or results which needs to be interpreted by professional (CK test).  A comment on disclosure as the manufacturer of the medical device IVD need to be careful because the company can not "disclaim" themselves out of the testing results.
    2. I am not sure what you mean by EMR.
    3. Again this depends on how the information is being presented and handled, i.e. is the data in a lab going to a central record system (LIMS) or is the results for the patient themselves.

    ------------------------------
    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 3.  RE: Diagnostic Test Result Declarations

    This message was posted by a user wishing to remain anonymous
    Posted 28-Oct-2022 16:38
    This message was posted by a user wishing to remain anonymous

    Hi Richard,
    Thank you for your reply and for providing the information.
    We are offering a UTI Diagnosis in a point-of-care setting or at a doctor's office and the evaluation would just be identifying the pathogen causing UTI. Results would be interpreted by HCP.
    My second question was with respect to declarations presented on device display as compared to electronic medical records printouts. Based on your feedback, it seems there is no direct regulation by FDA as to what disclosures are to be made on the results screen on the device. Although I would like to know your thoughts on it.

    Thank you once again for providing insights.
    Original Message


  • 4.  RE: Diagnostic Test Result Declarations

    Posted 31-Oct-2022 05:47
    Hi,

    Yes, there is no specific regulation for what is presented on the device display.  My thoughts are review what similar products provide on the results display and medical records printout, what is considered "state of the art" for providing results, and making a statement how the user could either interpret or use the results.  Again, without specific information it would be hard to say, because already diagnosing UTI can have a number of factors including symptoms, medication being taken, and how the results are presented.

    ------------------------------
    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 5.  RE: Diagnostic Test Result Declarations

    This message was posted by a user wishing to remain anonymous
    Posted 31-Oct-2022 09:31
    This message was posted by a user wishing to remain anonymous

    Hi Anon,

    Normally you would display the results in the format that is commonly accepted by the medical practitioners (specialists), hence it is advisable to:
    1. look at the relevant literature for the ranges and/or limits defined for that particular pathogen (depending on its intended use - qualitative or quantitative results).
    2. talk to the medical practitioners (specialist) to better understand what is widely accepted range/limit which defines the onset of the disease and/or late stage of the disease, ie what would be a meaningful display for them.
    3. test your display in intended use environment (usability testing).

    "My second question was with respect to declarations presented on device display as compared to electronic medical records printouts."

    The intended use/user will define your answer to that and whether the device is integrated (or has the option to interoperate) into an EMR. 

    Best regards
    Original Message


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