Good day Anon,
These type of questions can always be a bit subjective and likely will gather different opinions or thoughts. For me, it would not necessarily require a new 510(k) submission even though the methods or protocols may not be the same, even if a protocol was not done before, generally would not see this as requiring a new 510(k) submission. Where a new submission might be needed is when the packaging materials are changing enough which would then require quite a different testing method for the packaging materials. The other type of significant change is where the sterility method has changed or the packaging which may impact the sterility method. Of course further detail would be needed, but from the information provided most likely would not need a new 510(k) - this is documented completely in the memo to file/letter to file as you state.
------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------
Original Message:
Sent: 30-Jan-2023 15:33
From: Anonymous Member
Subject: 510(k) Documentation to File--Packaging Change
This message was posted by a user wishing to remain anonymous
We are changing our product packaging configuration and the new configuration is comprised of the same packaging materials as the previous configuration. We plan to document the technological change as a memo to file for US. A full packaging validation study is planned, including shipping/distribution testing, etc. According to the FDA Guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device Guidance for Industry and Food and Drug Administration Staff issued October 25, 2017, ...where methods or protocols that are not described in a previously cleared 510(k) are used to support new package integrity or shelf-life claims, submission of a new 510(k) is likely required. The 510(k) on file contains a packaging validation protocol with details of the test methods performed to validate the packaging, however, we are using a new protocol as our template has been updated to be more comprehensive in the past few years and we are performing a different test to evaluate seal integrity (dye penetration vs. bubble leak). Does this constitute a change in protocol or methods according to FDA?