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  • 1.  DICOM conformance

    This message was posted by a user wishing to remain anonymous
    Posted 24-Jan-2020 09:57
    This message was posted by a user wishing to remain anonymous

    Hi RAPS members,

    Does FDA require submission of DICOM conformance statement with the 510(k)?

    What kind of testing is required to claim DICOM standard conformance?

    What documents should be submitted to FDA for claiming conformance with DICOM conformance standard? Is there a guidance document?

    Thanks in advance.




  • 2.  RE: DICOM conformance

    Posted 26-Jan-2020 10:51
    I assume that you are doing a submission for some type of PACS, hence the question about DICOM conformance.

    To answer your question, the answer is no, FDA does not require this.

    For conformance, it is not so much a matter of testing as it is a matter of design. The DICOM standard is available here:
    https://www.dicomstandard.org/current/

    In addition there is a comparable ISO Standard ISO 12052:2017 which is rarely asked for.

    If you are developing a PACS, it is a good idea to make the DICOM conformance statement available to end users.

    Coming back to the FDA submission, you can include this in the section on Declarations of Conformity as a non-recognized standard.

    ------------------------------
    Jean Bigoney PhD, RAC, CQE
    Regulatory Affairs Specialist
    Morrisville NC
    United States
    ------------------------------

    Original Message


  • 3.  RE: DICOM conformance

    This message was posted by a user wishing to remain anonymous
    Posted 27-Jan-2020 09:09
    This message was posted by a user wishing to remain anonymous

    Hi Jean,

    Thanks for your kind reply.

    This submission is for a device that communicates with PACS and imports images stored on PACS.

    We are claiming compliance to FDA recognized standard NEMA PS 3.1 - 3.20 (2016), so I am thinking of submitting DICOM conformance statement. Also, we have  DICOM conformance design requirements to ensure communication with PACS. I believe FDA would like to see the objective evidence that we tested DICOM conformance. Please let me know if this doesn't sound correct.
    Original Message


  • 4.  RE: DICOM conformance

    Posted 27-Jan-2020 11:38
    Certainly you can claim conformance to the 2016 NEMA standard if you want to. FDA does not require it. And considering the rapid changes to the NEMA standard (they are already on the 2020 version, I'm not sure what value conformance to the older version would have for the product.

    If it were my submission, and if we wanted to include DICOM, I would include a Declaration of Conformity to the current, non-recognized NEMA 2020 version and include the DICOM.conformance statement using the NEMA template. Otherwise, you could also.use the FDA recognized version from 2016 or, if you are planning to market internationally, the ISO 12052:2017 non-recognized standard.

    ------------------------------
    Jean Bigoney PhD, RAC, CQE
    Regulatory Affairs Specialist
    Morrisville NC
    United States
    ------------------------------

    Original Message


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