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  • 1.  Alternativ to ESG portal for MDR reporting?

    This message was posted by a user wishing to remain anonymous
    Posted 10-Apr-2023 08:09
    This message was posted by a user wishing to remain anonymous

    Hello, 

    I am responsible for complaints handling and vigilance reporting at my company. I now have and incident that should be reported to the FDA regarding one of our devices.
    I have an account in the ESG portal and thought everything was working well but when trying to submit the report the certificate is not accepted. Despite various sessions with my IT support and communication with ESG Helpdesk the issue has not been solved and I am now reaching the deadline for reporting. 
    I'm therefore looking for a back-up plan, is there an alternative way to send MDR reporting for a device than through the ESG portal?

    Thanks in advance!
    Best, 
    Slightly desperate RA Manager



  • 2.  RE: Alternativ to ESG portal for MDR reporting?

    Posted 10-Apr-2023 10:59

    If you are having trouble getting FDA's ESG portal to work for you because of rejected digital certificates, then there there are at least a couple of alternatives.  Specifically, you can seek expert third party assistance getting your digital certificate issues resolved; and/or in the meantime while your digital certificate issues are being resolved, you can have a third party submit the eMDRs on your behalf using the third party's ESG account.  That is a service that I, and probably others, in the Forum can offer.

    During times of complete desperation, a less viable option is to, as an interim measure, submit the MDR directly to FDA's MDR Team with an explanation that you haven't yet been able to get your ESG submissions to work.  Be aware that FDA will reject such a submission method and you will eventually still need to submit the eMDR via the ESG..  But you will at least have shown in good faith your intent to inform the agency of the reportable adverse event.

    And here are some pointers for getting your FDA ESG digital certificates to work:

    • The digital certificates authenticate the sender (kind of like a digital signature would).
    • The sender must have two certificates: a "Public Key" certificate (file type .cer) and a "Private Key" certificate (file type .pfx).
      Together, these seem to meet the X.509 specification requirement.
    • These certificates expire and will need to be renewed on a periodic basis.
    • Keep your certificate files accessible at a known location on your computer.
    • To see if they are not expired, click on the .cer file and a window will pop up with certificate details.
    • If expired, then you will need to obtain new certificates.
    • Once obtained, export the Public Key and Private Key (the .cer and .pfx files) (see https://www.fda.gov/industry/about-esg/esg-appendix-c-digital-certificates).
    • Install them.
    • Update the Public Key (the .cer file) needs to be uploaded into your User Portal at https://esgportal.fda.gov/.
    • Once that upload is completed, then submissions should be accepted via your ESG production account.
    • Note that when making an actual ESG submission, the .pfx certificate file is the one that is linked/uploaded as part of the ESG submission, not the .cer certificate file, so be sure your linking the correct one, or the ESG submission will fail.



    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


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