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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Original Message:
Sent: 30-Jan-2023 11:38
From: Anonymous Member
Subject: Change modular PMA plan to traditional PMA submission
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?