When submitting a Q-SUB (Quality Submitting) supplement in response to feedback from the FDA, you typically do not need to repeat the information that was included in the original Q-SUB. Instead, you should focus on addressing the specific feedback provided by the FDA and providing any additional information or clarification that may be requested.
The format of a Q-SUB supplement will vary depending on the type of information being provided and the specific requirements of the FDA. However, it is generally a good practice to clearly identify the supplement as such and to clearly reference the original submission and the specific feedback being addressed.
A typical format for a Q-SUB supplement could include:
- A cover letter or introduction that identifies the supplement and provides an overview of the information being provided
- A section addressing the specific feedback from the FDA, including any additional information or clarification requested
- A questions section, if needed, to ask for further clarification or guidance from the FDA
- Supporting documents, such as test results or other data, that provide additional information about the product or process being submitted
It is important to consult the FDA guidance document related to the specific product or process you are submitting and follow their guidelines. It is also recommended to work closely with the FDA to ensure that your supplement is complete and properly addresses any questions or concerns they may have.
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Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets -
https://www.twitch.tv/edosani------------------------------
Original Message:
Sent: 11-Jan-2023 17:30
From: Anonymous Member
Subject: FDA Q-Sub Supplement Format
This message was posted by a user wishing to remain anonymous
We submitted a Q-SUB and obtained FDA's feedback.
We want to comment and ask additional questions about the feedback and consider a Q-SUB supplement.
Do we need to repeat the information submitted in the original Q-SUB other than the questions section?
What is an acceptable supplement format?