We handle any product name changes by including this in a "Change Summary" section at the beginning of the main 510(k) document, where we also describe any changes made to the device itself since our last communication with the agency (usually a presub).
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Kristen Kanack PhD
SVP, Regulatory and Clinical Affairs
Salt Lake City, UT
United States
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Original Message:
Sent: 30-Oct-2019 09:11
From: James Davis
Subject: Product Name Change for submission
I was thinking of just the cover letter but might reference in both places actually, thanks James.
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James
Head of QARA
UK
Original Message:
Sent: 30-Oct-2019 08:02
From: James Bonds
Subject: Product Name Change for submission
The best way that I have seen to address this it that there is a "project" name that is applied in the R&D phase, then a "product" name that is applied when the device is ready to market. This is not an uncommon situation, and in fact there are some devices that have multiple product names across different geographies. This can easily be explained, either in the cover letter or Executive Summary.
Regards,
James
Original Message------
Hi All.
During development we have decided to change the marketing name of our device and I was wondering where best to describe this once we are ready for our 510(k) submission? I was thinking of summarizing in the cover letter and wondered what other people thought?
I want to highlight in the Technical File because we have had a pre-sub under one product name but will be submitting under a new name! There is no change in the product in any way from what the FDA has seen, it is purely a marketing name change.
Thanks
James
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James
Head of QARA
UK
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