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  • 1.  Change modular PMA plan to traditional PMA submission

    This message was posted by a user wishing to remain anonymous
    Posted 30-Jan-2023 11:48
    This message was posted by a user wishing to remain anonymous

    I submitted the modular PMA shell to FDA.  Now I want to change mind to do the traditional PMA submission. What is the consequence? Do I need to withdraw the shell?



  • 2.  RE: Change modular PMA plan to traditional PMA submission

    Posted 31-Jan-2023 04:14
    Hello Anon,

    You can switch from a Modular PMA submission to a traditional PMA submission, though really depends where you are in the stage of your Module process.  Start communication with your Lead Reviewer to inquire, discuss, and determine steps for switching as they are the one you should work with on switching over submission types.  If you are far along maybe even starting Module 4/Clinical Data they might want to just continue as planned.  If you are just finishing a review of Module 1, then might not be an issue.  Definitely reach out to your Lead Reviewer as this does happen and they will (should) be quite open to discuss this with your organisation.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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  • 3.  RE: Change modular PMA plan to traditional PMA submission

    Posted 31-Jan-2023 09:15
    Hello,
    I would suggest you initiate this by talking to your assigned lead reviewer. If you haven't been assigned with a lead reviewer than I would suggest you start with your branch chief. 
    If I was reaching out to FDA, I would provide them with a rationale for the change in your proposal. 

    Thank you
    Shiven

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    [Shiven]
    [Regulatory Affairs]
    [San Francisco] [CA]
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