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  • 1.  MDDS labeling symbols

    This message was posted by a user wishing to remain anonymous
    Posted 18-Aug-2021 17:08
    This message was posted by a user wishing to remain anonymous

    Hi RAPS,

    We have an MDDS that will be used for the transfer of CT scans from the scan center to case planners (Class II surgical device), and I was wondering if we need the "RX Only" symbol on the IFU/checklist for the MDDS. We have the symbol on our existing documents that go to the scan center for the current data transfer methods (USB/CD), but I'm not really sure if "prescription-only" is required for scan centers on how to share the images. The other side of the coin is - 

    a) having the symbol for the entire process, which, being a CT scan, is physician-guided
    b) consistency across documents

    I have tried going through the guidance documents for MDDS and the Multiple Function Device and could not come up with a conclusive answer.

    Appreciate any thoughts, advice, guidance referrals.

    Thanks!


  • 2.  RE: MDDS labeling symbols

    Posted 19-Aug-2021 08:37
    Greetings Anon,

    Working with a many different software only applications, typically the Rx symbol is either located in the splash screen or About menu option, similar to where all the other "regulatory" information is kept like UDI, version, etc.  This could and often is located on any printed or electronic IFU as well.  I am not sure you would necessarily need it through the entire process since by default would only be used and accessed by physicians or trained professionals.  After submitting numerous 510(k) and even Tech Doc files, just having the Rx or prescription statement conspicuously located on the "information supplied to user" should be sufficient.  I know of applications which do have statements or pop-up windows about use of software application is limited to trained, qualified personnel, so maybe instead of having the Rx symbol everyone, you could have some statement like this in key areas of the workflow.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: MDDS labeling symbols

    Posted 20-Aug-2021 16:03
    MDDS is not regulated as a medical device so I'm not sure why you would need an Rx symbol at all.

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    Michael Zagorski RAC
    Director of Regulatory Affairs
    Pittsburgh PA
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    Original Message


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